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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT DIABETES CARE, INC. FREESTYLE LIBRE 14DAY SENSOR SENSOR, GLUCOSE, INVASIVE

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ABBOTT DIABETES CARE, INC. FREESTYLE LIBRE 14DAY SENSOR SENSOR, GLUCOSE, INVASIVE Back to Search Results
Device Problem Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problem Overdose (1988)
Event Date 06/26/2019
Event Type  Injury  
Event Description
Freestyle libre 14 day monitor gave wrong glucose readings affecting insulin dosages. Sensor failed completely after 10 days. This is the second sensor with problem. My a1c reading went from 6. 7 to 7. 3 due to incorrect dosing of insulin based on inaccurate readings. Finger stick readings confirmed inaccurate cgm readings. Fda safety report id# (b)(4).
 
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Brand NameFREESTYLE LIBRE 14DAY SENSOR
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
ABBOTT DIABETES CARE, INC.
MDR Report Key8758233
MDR Text Key150136055
Report NumberMW5087804
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 06/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/01/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 07/01/2019 Patient Sequence Number: 1
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