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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
Lot Number 6284844
Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/26/2021
Event Type  malfunction  
Event Description
I applied the freestyle libre 2 blood glucose sensor.After activation the unit began to report erroneously high blood glucose levels.The levels were compared to a contour blood glucose monitor and the libre 2 values remained extremely high despite my efforts to control my blood glucose level.I eventually removed the sensor and phoned the manufacturer.They collected information about the sensor and the reader and offered a free replacement.At this point i have little confidence in the device.I have previously been very successful in maintaining my blood glucose levels within the desired range.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 Key12392197
MDR Text Key269424104
Report NumberMW5103604
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 08/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date10/31/2021
Device Lot Number6284844
Was Device Available for Evaluation? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/30/2021
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Age69 YR
Patient Weight70
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