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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC. FREE STYLE LIBRE GLUCOSE MONITOR
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ABBOTT DIABETES CARE INC. FREE STYLE LIBRE GLUCOSE MONITOR Back to Search Results
Model Number 71525-01
Device Problems Use of Device Problem (1670); High Test Results (2457)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/16/2017
Event Type  malfunction  
Event Description
I acquired an abbott freestyle glucose meter on (b)(6) 2017 and sensors for the meter on (b)(6) 2017.During the first two weeks of (b)(6) 2018, i observed that my readings using the sensors were consistently inaccurately higher than they should be (as shown by my accu-check strip meter).I reported this problem to abbott labs and received a certificate for a free sensor.On (b)(6) 2018, i visited dr.(b)(6), my endocrinologist at (b)(6).She referred me to (b)(6), (b)(6) diabetes educator.She told me that she had tested the freestyle libre to test how it works and its accuracy.She indicated to me that the results of readings with the libre were consistently 30 percent higher or more than acu check pricked readings.
 
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Brand Name
FREE STYLE LIBRE GLUCOSE MONITOR
Type of Device
FREE STYLE LIBRE GLUCOSE MONITOR
Manufacturer (Section D)
ABBOTT DIABETES CARE INC.
MDR Report Key7288886
MDR Text Key100790065
Report NumberMW5075413
Device Sequence Number0
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 02/20/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number71525-01
Device Catalogue Number71525-01
Device Lot Number03Y307D
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received02/21/2018
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age72 YR
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