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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC. FREESTYLE LIBRE FLASH GLUCOSE MONITORING SYSTEM

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ABBOTT DIABETES CARE INC. FREESTYLE LIBRE FLASH GLUCOSE MONITORING SYSTEM Back to Search Results
Model Number 71525-01
Device Problem False Reading From Device Non-Compliance (1228)
Patient Problem Hypoglycemia (1912)
Event Date 03/10/2018
Event Type  Injury  
Event Description
I received a prescription for the freestyle libre glucose monitoring system. I found out very quickly that it reads high by over 100 points. So if my true finger stick glucose reading is 150, the meter would read 250 or higher, usually higher. I relied on it and went crashing down to 40 on my glucose. Not one to give up, i tried three more of the skin insert reading disks, and even purchased a second test meter. Same thing. Abbott labs has all their customer assistance off shore and you cannot speak to anyone here in the us. They tried repeatedly to tell me it was my fault that i must be using it wrong. After many calls one supervisor said they would escalate my complaint and i would hear back from them. That was ten days ago. I will quit using this item but i fear others will get hurt or go into diabetic shock by relying on the false readings. I have been a pump wearing type one diabetic for 18 years, so i am pretty familiar on how to use medical devices.
 
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Brand NameFREESTYLE LIBRE FLASH GLUCOSE MONITORING SYSTEM
Type of DeviceFREESTYLE LIBRE FLASH GLUCOSE MONITORING SYSTEM
Manufacturer (Section D)
ABBOTT DIABETES CARE INC.
MDR Report Key7352165
MDR Text Key102961861
Report NumberMW5075948
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 03/18/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/19/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number71525-01
Device Lot Number02Y334D
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: 03/19/2018 Patient Sequence Number: 1
Treatment
OMNI POD INSULIN PUMP
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