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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
Device Problems Device Alarm System (1012); Incorrect, Inadequate or Imprecise Resultor Readings (1535); Device Slipped (1584)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/21/2019
Event Type  malfunction  
Event Description
For the past 18 months or so, i have been using a freestyle libre to help with my type 1 diabetes. I have put up with inaccurate readings, which have varied almost 50% (libre 240 vs lite 150). I have tolerated the variability as it does show trends. The last two 14 day sensors i used lasted only a few days (12 hours and 2 days). While abbott did mail me replacements, it was very inconvenient when i was on vacation in (b)(6) as they could not mail me a replacement and i barely had enough regular test strips for my trip. I also get numerous messages from the libre reader to check my glucose with test strips. These sensors are expensive, even with insurance as my insurer's "contracted price" is 25% over (b)(6). Having type 1 diabetes is difficult and expensive enough without sub-par products. It is a great idea, but it has failed my expectations. They went me to send the sensor back to them. I did send the first one, but still have the second. Also they do not stay on well when it is hot and you sweat. 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 Key8758799
MDR Text Key150155431
Report NumberMW5087823
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 07/01/2019
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received07/02/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/31/2019
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: 07/02/2019 Patient Sequence Number: 1
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