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U.S. Department of Health and Human Services

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

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ABBOTT LABORATORIES / ABBOTT DIABETES CARE INC. FREESTYLE LIBRE 14 DAY SENSOR SENSOR, GLUCOSE, INVASIVE Back to Search Results
Model Number ABC 8: 10190382
Device Problem Difficult to Remove (1528)
Patient Problems Pain (1994); Foreign Body In Patient (2687)
Event Date 03/17/2021
Event Type  Injury  
Event Description
Freestyle libre 14 day sensor filament not removed when sensor disc accidentally knocked off. Pt complained of arm pain today, and provider made small incision and removed filament. No observed signs or symptoms of infection. Fda safety report id# (b)(4).
 
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Brand NameFREESTYLE LIBRE 14 DAY SENSOR
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
ABBOTT LABORATORIES / ABBOTT DIABETES CARE INC.
alameda CA 94502
MDR Report Key11530088
MDR Text Key241519261
Report NumberMW5100132
Device Sequence Number1
Product Code MDS
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 03/17/2021
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received03/18/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberABC 8: 10190382
Device Catalogue NumberCARDINAL: 5479084
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
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? No
Type of Device Usage

Patient Treatment Data
Date Received: 03/18/2021 Patient Sequence Number: 1
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