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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT LABS /ABBOTT DIABETES CARE INC. FREESTYLE LIBRA 14 DAY BLOOD GLUCOSE MONITOR SENSOR, GLUCOSE, INVASIVE

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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 Resultor 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).
 
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Brand NameFREESTYLE LIBRA 14 DAY BLOOD GLUCOSE MONITOR
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
ABBOTT LABS /ABBOTT DIABETES CARE INC.
MDR Report Key13506573
MDR Text Key285531392
Report NumberMW5107360
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 02/07/2022
5 Devices were Involved in the Event: 1   2   3   4   5  
1 Patient was Involved in the Event
Date FDA Received02/09/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No Answer provided

Patient Treatment Data
Date Received: 02/09/2022 Patient Sequence Number: 1
Treatment
GLUCOPHAGE; LIPITOR
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