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Daily blood sugar (glucose) monitoring is a cornerstone of effective diabetes management and glycemic control. 1 Results from self-monitoring systems help patients adjust dietary intake and insulin dosing and help physicians adjust the timing and amounts of oral medications. Maintaining the correct target range for blood glucose is critical for averting the many complications diabetes can cause 2 3 4 5 6 7—so any interruption of glucose monitoring can have potentially dangerous consequences.
Abbott manufactures a cadre of home glucose testing systems for diabetic patients. The systems include a palm-sized meter, test strips, and calibrated lancets for obtaining blood samples.
Recalled Abbott Glucose Monitoring Systems
In the late fourth quarter of 2013 throughout the second quarter of 2014, Abbott recalled a number of home glucose monitoring systems—either the test strips, meters, or both. All the meters affected have similar capabilities: 8 9 10
- The range of glucose values they report (20 – 500 mg/dL)
- The number of test results they can store (400)
- The week- or month-long trending information they can display
- The steps of the testing procedure
Troubleshooting Abbott Test Strips
The meters provide audible prompts when sufficient sample is loaded onto the strip, as well as when the result displays. Any result less than 60 mg/dL warrants repeating. If the result displays the word “LO” instead of a number, that requires troubleshooting, starting with running a control to ensure that the vial of test strips and the meter are working properly. Three levels of controls are provided with the glucose monitoring system; an out-of-range result for a control should prompt a call to Abbott Diabetes Care. Any result greater than 240 mg/dL should be repeated. Similarly, a result that displays only as the word “HI” should prompt the user to repeat the test.8 – 10 High results (above 240 or “HI”) indicate hyperglycemia—insufficient insulin in the body—and 240 mg/dL is the traditional cutoff for indicating that the body is progressing into ketoacidosis, a serious and sometimes life-threatening condition.2
Accurate self-test results depend on both user technique as well as technology. The latter has been an issue in recent months with Abbott’s multiple recalls of both test strips and glucose meters. Between November 2013 and March 2014, Abbott recalled two kinds of test strips used exclusively with several kinds of meters. 11 In addition, it recalled several types of meters. 12 13 The reasons for the recalls are related, despite them straddling multiple product lines.
Too-low dosing of antiglycemic agents can lead to hyperglycemia (high blood sugar) and potentially serious consequences. Notably, all of Abbott’s glucose meter user manuals—and its recall notices—urge patients to seek medical help if their testing results do not match the way they feel.
Dangers of Under-Reported Glucose Results
Problems noted with the recalled test strips were two-fold. The official reason for the recalls was erroneously low readings; however, patient calls to Abbott also documented erratic readings—for example, a Type 2 diabetic not on insulin who had more than 100% difference in readings on the same meter five minutes apart. Other patients reported control results much lower than established values and test results varying by 50% to 500% when using the same box of test strips on different meters.14
Erroneously low results can result in using insufficient medication to maintain a healthy blood sugar level. Too-low dosing of antiglycemic agents can lead to hyperglycemia (high blood sugar) and potentially serious consequences (see sidebar). Notably, all of Abbott’s glucose meter user manuals—and its recall notices—urge patients to seek medical help if their testing results do not match the way they feel.8 – 10, 12, 13
Due to the grave health risk that underreporting of glucose results can cause, all of the recent recalls are Class I, the most serious type of recall. 14 15 In fact, serious medical harm did occur. One Type 1 diabetes patient who had repeatedly false low readings died from hyperglycemia and diabetic ketoacidosis. Other patients reported symptoms of overt high blood sugar, including fatigue and feeling faint.14
FreeStyle and FreeStyle Lite test Strips
Abbott recalled FreeStyle and FreeStyle Lite test strips, which are used exclusively with glucose meters bearing the same name. However, the FreeStyle Flash meter also exclusively uses FreeStyle strips. Ditto for the OmniPod Insulin Management system—an insulin pump that comes with a built-in FreeStyle glucose meter.
Being able to use only one kind of meter and/or strip creates double trouble: an immediate problem of availability, as well as a reimbursement issue. Insurance coverage for many people with diabetes allows reimbursement for only one kind of meter and test strip. If the meter doesn’t work properly—regardless of whether the culprit is the meter itself or the test strips used—then patients who don’t own an alternate meter to use must either wait for the recall process to sort itself out or pay out of their own pocket for a different [non-reimbursible] model or brand of meter from their physician or pharmacy. This scenario is especially true for Medicare patients and is a result of Medicare’s Competitive Bidding Program. Medicare will not cover the cost of meters and supplies unless they’re provided by contracted suppliers. 16
FreeStyle and Freestyle Lite Glucose Meters and Recalls
A somewhat murkier issue is Abbott’s glucose meter recalls, which lagged behind test strip recalls. Abbott recalled its FreeStyle Glucose Meter five months after recalling its FreeStyle Test Strips (see chart). Interestingly, Abbott recalled the FreeStyle Flash meter 12 on March 14, 2014—less than a month after a previous letter (02/19/2014) stated the meter was fine and the test strips were the only issue of concern. 17
Abbott’s official communications with patients indicated that the FreeStyle, FreeStyle Lite or FreeStyle Flash meters themselves were not the source of the problem. However, Abbott said that they may “produce erroneously low blood glucose results when using FreeStyle Lite and FreeStyle Blood Glucose Test Strips.”12, 13 No communication mentions whether any meter failed to properly display the startup screen or any other technical issue (such as recording or storing data, not working properly at recommended temperatures).
Neither the FreeStyle or Freestyle Lite Glucose Meter has been in production since 2010. 13, 18
Abbott’s April 23, 2014, communication to OmniPod Insulin Management System users said not to use existing or replacement FreeStyle test strips with an expiration date earlier than August 2015. 19 Similar guidelines do not appear to be part of Abbott’s recall notices for the FreeStyle and FreeStyle Lite strips used with other meters.
All this information and more is summarized in this chart that shows the device recalled, its recall date, the problem that prompted the recall, and Abbott’s resulting actions/provisions.
Recall Letter and Patient Safety
Abbott’s recall letters of all the aforementioned test strips and meters repeatedly urged patients to continue testing their glucose using the same meter if they did not have a replacement or alternate to use.12,13
Some patients reported waiting more than three weeks for replacement meters.14
Past Glucose Test Strip Recalls
This isn’t the first time that Abbott has recalled FreeStyle and FreeStyle Lite Test Strips. Both were previously recalled in Dec. 2011, along with five other kinds of glucose test strips. FreeStyle Lite strips were also recalled in Sept. 2008. 20
The last time an Abbott glucose meter was recalled for an obvious meter malfunction was May 9, 2013. The FreeStyle InsuLinx Glucose Monitoring System was reported to display erroneously low results when a patient’s glucose was very high. The displayed number was reportedly 1,024 mg/dL lower than the measured/actual result.13
|Summary of 2014 Abbott Recalls|
|Device||Recall Date||Problem||Abbott Action/Provision|
|FreeStyle Test Strips||11/18/2013||Officially: erroneously low readingsPatient reports: erroneously low readings and also erratic readings—up to 5-fold difference in results compared with other meters||Replace the strips at no charge.
Use the same meter if you don’t have a replacement or alternate meter to use.
Test using the control solution.
Discontinue using a vial of test strips if results from control solutions are not within the expected range.
See your doctor if your results don’t match how you feel.
|FreeStyle Lite Test Strips||12/17/2013|
|FreeStyle Blood Glucose Monitor System||03/18/2014||Same reason as given for test strips||Replace meters at no charge.
Same instructions as for test strips regarding what to do while waiting for replacement
|FreeStyle Lite Glucose Monitoring System||12/17/2013|
|FreeStyle Flash Meter||02/19/14
FreeStyle Test Strips
recalled for this meter03/14/14
Flash meter recall
|OmniPod Insulin Management System
(insulin pump with built-in glucose meter)
|11/05/2013||Contains a FreeStyle Glucose Meter that uses only FreeStyle Test Strips
Same problem as above with test strips
Unconfirmed reports of meters made in China generating too high readings
|Keep using the OmniPod to deliver insulin BUT
Measure glucose using the FreeStyle Freedom blood glucose meter received with your welcome pack
|FreeStyle InsuLinx Glucose Monitoring System||05/09/2013||Incorrect results at very high glucose levels; displayed value 1,024 mg/dL lower than measured/actual result||Get a software update
Replace the meter (only at patient request)
Mahoney J, Ellison J. Assessing the Quality of Glucose Monitor Studies: A Critical Evaluation of Published Reports. Clin Chem. 2007;53(6):1122–1128. ↩
The Merck Manual Professional Edition. Diabetes mellitus.
http://www.merckmanuals.com/professional/endocrine_and_metabolic_disorders/diabetes_mellitus_and_disorders_of_carbohydrate_metabolism/diabetes_mellitus_dm.html. Accessed September 23, 2014. ↩
Piette JD, Kerr E. The impact of comorbid chronic conditions on diabetes care. Diabetes Care. 2006;29:725-31. ↩
Long AN, Dagogo-Jack S. Comorbidities of Diabetes and Hypertension: Mechanisms and Approach to Target Organ Protection. J Clin Hypertension. 2011;13(4):244-251. ↩
Fowler MJ. Microvascular and Macrovascular Complications of Diabetes. Clinical Diabetes. 2008;26(2):77-82. ↩
The IDF consensus worldwide definition of the Metabolic Syndrome. International Diabetes Foundation Communications. 2006. ↩
Mayo Clinic website. Hyperglycemia. http://www.mayoclinic.org/diseases-conditions/hyperglycemia/basics/symptoms/con-20034795. Accessed September 20, 2014. ↩
Abbott. FreeStyle Lite Glucose Monitoring System Owner’s Booklet. DOC23624_Rev-B 06/14. ↩
Abbott. FreeStyle Flash Glucose Monitoring System Owner’s Booklet. ART03992 Rev B 10/05. ↩
Abbott. FreeStyle InsuLinx Glucose Monitoring System Owner’s Booklet. ART23294-005 Rev. A 02/14. ↩
U.S. Food and Drug Administration. Abbott Diabetes Care, FreeStyle and FreeStyle Lite Blood Glucose Test Strips – Erroneously Low Blood Glucose Results. November 18, 2013. ↩
Abbott Diabetes Care. Urgent Product Recall: FreeStyle Flash and FreeStyle Blood Glucose Monitoring Systems. February 19, 2014. DOC 33193-Rev-A-09/14. ↩
Abbott Diabetes Care. Urgent Product Recall: FreeStyle InsuLinx Blood Glucose Meter. April 13, 2013. ADC-00035 Ver 1.0 06/14. ↩
U.S. Food and Drug Administration. Safety: Background and Definitions. http://www.fda.gov/Safety/Recalls/ucm165546.htm. Accessed September 21, 2014. ↩
U.S. Food and Drug Administration. Recalls, Corrections and Removals (Devices). http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/RecallsCorrectionsAndRemovals/default.htm. Accessed September 22, 2014 ↩
Medicare website. Blood sugar (glucose) test strips. http://www.medicare.gov/coverage/blood-sugar-test-strips.html. Accessed September 23, 2014. ↩
Abbott Diabetes Care website. Abbott Issues Recall of Certain Blood Glucose Monitoring Systems. [press release]. March 14, 2014. https://www.abbottdiabetescare.com/press-room/2014/2014-d.html. Accessed September 17, 2014. ↩
U.S. Food and Drug Administration. Safety Alerts for Human Medical Products. http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm389367.htm Accessed September 19, 2014. ↩
Abbott Diabetes Care website. Additional Information for FreeStyle Blood Glucose Meters Built into the OmniPod® Insulin Management System. https://www.abbottdiabetescare.com/press-room/2014/2014-c.html. Accessed September 23, 2014. ↩
U.S. Food and Drug Administration. Medical Device Recalls. http://google2.fda.gov/search?q=Abbott&filter=0&proxystylesheet=FDAgov&output=xml_no_dtd&sort=date%253AD%253AL%253Ad1&site=FDAgov-Recalls-Devices&requiredfields=-archive%3AYes&client=FDAgov. Accessed September 22, 2014. ↩