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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC. FREESTYLE LIBRE 2 SENSOR, GLUCOSE, INVASIVE

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ABBOTT DIABETES CARE INC. FREESTYLE LIBRE 2 SENSOR, GLUCOSE, INVASIVE Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problem Rash (2033)
Event Date 05/18/2022
Event Type  Injury  
Event Description
Libre freestyle 2 sensor caused major hives and rash at site. Fda safety report id # (b)(4).
 
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Brand NameFREESTYLE LIBRE 2
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
ABBOTT DIABETES CARE INC.
MDR Report Key14494875
MDR Text Key292961527
Report NumberMW5109893
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 05/21/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/24/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided

Patient Treatment Data
Date Received: 05/24/2022 Patient Sequence Number: 1
Treatment
INSULIN; LEVOTHYROXINE; ZOLOFT
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