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U.S. Department of Health and Human Services

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

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ABBOTT DIABETES CARE INC. FREESTYLE LIBRE 14 DAY SENSOR, GLUCOSE, INVASIVE Back to Search Results
Model Number ART28261 REV A 10/17
Device Problem Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
I am advising the fda to further review the abbott freestyle libre 14 day system. I have been a user of this for just over one year. In that time, i have encountered multiple sensor issues. Some giving inaccurate reading as confirmed by a separate finger stick system. I've also had 2 sensors stop working completely in under a week. After reviewing multiple websites i'm finding that i'm not alone with this experience. This is proving to be a very unreliable system. Their website is misleading by stating you can reduce finger pricks. What's the point of the system if it's always so far off that you have to verify by a finger stick. It has been my experience that this system is unreliable and costly. If it hasn't happened yet someone will make a bad diabetic management decision based on the inaccuracies in the system. Today i was left without a way to test due to another unexpected failure. I will no longer rely on the system and will carry a second tester. Once my remaining sensors fail, i will be throwing this system away. It is that bad. Fda safety report id # (b)(4).
 
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Brand NameFREESTYLE LIBRE 14 DAY
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
ABBOTT DIABETES CARE INC.
MDR Report Key11776547
MDR Text Key249435689
Report NumberMW5101158
Device Sequence Number1
Product Code MDS
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 05/02/2021
2 Devices were Involved in the Event: 1   2  
0 Patients were Involved in the Event:
Date FDA Received05/04/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberART28261 REV A 10/17
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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