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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC. FREESTYLE LIBRE 2; SENSOR, GLUCOSE, INVASIVE
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ABBOTT DIABETES CARE INC. FREESTYLE LIBRE 2; SENSOR, GLUCOSE, INVASIVE Back to Search Results
Model Number LIBRE 2
Device Problems Product Quality Problem (1506); Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/16/2021
Event Type  Injury  
Event Description
I have been using a freestyle libre2 continuous glucose monitor for several months.During that time, i have had consistent problems with sensors failing to work, either failing off, or not working correctly on start-up.It hurts every time i install these sensors and it cost significant money to replace each sensor.Abbott has replaced the failing sensors when i call their customer service number.The concern i have is that this product has serious quality control issues and needs to be retested by the fda to ensure it is truly safe and effective.I have been installing the sensors as directed by abbott and am not a super active person.At this point i think abbott has replaced 6 sensors due to their failure.Fda safety report id# (b)(4).
 
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Brand Name
FREESTYLE LIBRE 2
Type of Device
SENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
ABBOTT DIABETES CARE INC.
MDR Report Key12506575
MDR Text Key272683608
Report NumberMW5104084
Device Sequence Number1
Product Code MDS
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 09/16/2021
6 Devices were Involved in the Event: 1   2   3   4   5   6  
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberLIBRE 2
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received09/20/2021
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Age50 YR
Patient Weight107
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