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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC. FREESTYLE LIBRE GLUCOSE MONITORING SYSTEM SESOR, GLUCOSE, INVASIVE

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ABBOTT DIABETES CARE INC. FREESTYLE LIBRE GLUCOSE MONITORING SYSTEM SESOR, GLUCOSE, INVASIVE Back to Search Results
Model Number FREESTYLE LIBRE READER + SENSOR
Device Problem No Display/Image (1183)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/10/2018
Event Type  malfunction  
Event Description
I could not get any glucose readings from the abbott freestyle libre reader and the sensor. I bought a new set of the same, which work fine.
 
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Brand NameFREESTYLE LIBRE GLUCOSE MONITORING SYSTEM
Type of DeviceSESOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
ABBOTT DIABETES CARE INC.
MDR Report Key8070564
MDR Text Key127342917
Report NumberMW5081231
Device Sequence Number0
Product Code MDS
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 11/08/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/13/2018
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/31/2019
Device Model NumberFREESTYLE LIBRE READER + SENSOR
Was Device Available for Evaluation? No
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: 11/13/2018 Patient Sequence Number: 1
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