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U.S. Department of Health and Human Services

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

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ABBOTT DIABETES CARE INC. FREESTYLE LIBRE 14 DAY SENSORS SENSOR, GLUCOSE, INVASIVE Back to Search Results
Lot Number 0M0060X723R
Device Problem Low Readings (2460)
Patient Problem Hyperglycemia (1905)
Event Date 12/06/2019
Event Type  malfunction  
Event Description
I started using freestyle libre 14 day sensor. I use my readings to determine my insulin dose. The sensor started giving me low reading and i adjusted my medicines accordingly. After a few days, i decided to check with a different method. My reading were over 300 and the libre's reading was 133. This has caused me to go several days without taking my insulin to prevent me from going to low. To find out it wasn't accurate. This is very dangerous for people trying to control their blood sugar. Fda safety report id# (b)(4).
 
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Brand NameFREESTYLE LIBRE 14 DAY SENSORS
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
ABBOTT DIABETES CARE INC.
MDR Report Key9451601
MDR Text Key170450076
Report NumberMW5091579
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 12/06/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/10/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/16/2019
Device Lot Number0M0060X723R
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

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