ABBOTT LABS /ABBOTT DIABETES CARE INC. FREESTYLE LIBRA 14 DAY BLOOD GLUCOSE MONITOR; SENSOR, GLUCOSE, INVASIVE
|
Back to Search Results |
|
Device Problems
Product Quality Problem (1506); Incorrect, Inadequate or Imprecise Result or Readings (1535); Defective Device (2588)
|
Patient Problem
Insufficient Information (4580)
|
Event Date 02/01/2021 |
Event Type
malfunction
|
Event Description
|
I have been using the freestyle libra 2 week diabetic sensors since they were introduced to the public.I am a type 2 diabetic.As a result, insurance does not cover the cost and i pay out-of-pocket for each device.During the 3+ years i have used the device, i have found an occasional defective unit.These were defective for various reasons.Sometimes the glue would be defective or not present and the sensor would not stay adhered for two weeks.Sometimes the units would begin to provide incorrect results, as verified by finger stick, prior to expiration at two weeks.The problems were sporadic.About one year ago i noticed the glue seemed to have improved and failure was no longer a big problem.At about the same time i noticed the sensors rarely provide accurate results for the stated two week period.Failure now occurs at about the ten day mark.Recently the failure rate has approached 100% as no sensor over the past 6 months (12 units) has lasted for the full 14 day period.As a result, i have begun returning defective units to abbott labs.What i am seeing is that the sensor slowly begins to fail by giving low blood glucose readings.These readings cause the user to over consume calories in order to compensate or may cause the user to believe they are near a life threatening diabetic coma situation.As someone who is familiar with fda manufacturing requirements i can absolutely attest that abbott devices are failing some part of the good manufacturing process requirements.This is a potentially life threatening situation.In addition, the failure rate is so high that it is a serious financial burden and potential windfall to abbott.I have returned three or four devices to abbott for their review.The unit in my photos failed after 10 days.I will retain this unit, and forego the potential replacement, should the fda wish to evaluate the unit in question.Sincerely, (b)(6).Fda safety report id # (b)(4).
|
|
Event Description
|
I have been using the freestyle libra 2 week diabetic sensors since they were introduced to the public.I am a type 2 diabetic.As a result, insurance does not cover the cost and i pay out-of-pocket for each device.During the 3+ years i have used the device, i have found an occasional defective unit.These were defective for various reasons.Sometimes the glue would be defective or not present and the sensor would not stay adhered for two weeks.Sometimes the units would begin to provide incorrect results, as verified by finger stick, prior to expiration at two weeks.The problems were sporadic.About one year ago i noticed the glue seemed to have improved and failure was no longer a big problem.At about the same time i noticed the sensors rarely provide accurate results for the stated two week period.Failure now occurs at about the ten day mark.Recently the failure rate has approached 100% as no sensor over the past 6 months (12 units) has lasted for the full 14 day period.As a result, i have begun returning defective units to abbott labs.What i am seeing is that the sensor slowly begins to fail by giving low blood glucose readings.These readings cause the user to over consume calories in order to compensate or may cause the user to believe they are near a life threatening diabetic coma situation.As someone who is familiar with fda manufacturing requirements i can absolutely attest that abbott devices are failing some part of the good manufacturing process requirements.This is a potentially life threatening situation.In addition, the failure rate is so high that it is a serious financial burden and potential windfall to abbott.I have returned three or four devices to abbott for their review.The unit in my photos failed after 10 days.I will retain this unit, and forego the potential replacement, should the fda wish to evaluate the unit in question.Sincerely, (b)(6).Fda safety report id # (b)(4).
|
|
Search Alerts/Recalls
|
|
|