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U.S. Department of Health and Human Services

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

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ABBOTT DIABETES CARE, INC. FREESTYLE LIBRE SENSOR, GLUCOSE, INVASIVE Back to Search Results
Model Number FREESTYLE LIBRE 14 DAY
Device Problems Loss of or Failure to Bond (1068); Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problems Erythema (1840); Irritation (1941); Swelling (2091)
Event Date 11/21/2019
Event Type  malfunction  
Event Description
The abbott freestyle libre reader was reading normal blood sugar level, but my glucose was actually 56. The sensors have been repeatedly failing after 6-8 days but they are approved for 14. The adhesive is irritating causing redness and swelling. The sensor adhesive begins failing after 5 days. I have my reading device that has some of the sensor failure dates, but i'm not sure how many. I did contact abbott and they authorized replacements but that doesn't work with prescriptions. Fda safety report id# (b)(4).
 
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Brand NameFREESTYLE LIBRE
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
ABBOTT DIABETES CARE, INC.
MDR Report Key9445889
MDR Text Key170281964
Report NumberMW5091554
Device Sequence Number2
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 12/05/2019
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received12/09/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberFREESTYLE LIBRE 14 DAY
Device Catalogue Number0M0060792NM
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 12/09/2019 Patient Sequence Number: 1
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