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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC FREESTYLE LIBRE PRO FLASH GLUCOSE MONITORING SYSTEM

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ABBOTT DIABETES CARE INC FREESTYLE LIBRE PRO FLASH GLUCOSE MONITORING SYSTEM Back to Search Results
Model Number 71562-01
Device Problem Detachment of Device or Device Component (2907)
Patient Problem Foreign Body In Patient (2687)
Event Date 12/18/2020
Event Type  Injury  
Manufacturer Narrative
At this time, product has not yet been returned and a valid serial number has not been provided. An extended investigation has been performed for the reported complaint, and there was no indication that the product did not meet specification. Clinical data was reviewed and confirmed that libre sensors continue to be safe, effective, and perform as intended in the field. A tripped trend review was conducted for the reported complaint and freestyle libre sensors; no trends were identified that would indicate any product related issues. If the product is returned, a physical investigation will be performed and a follow-up report submitted. The date the incident occurred is unknown. The date entered is the date abbott diabetes care became aware of the event. The device manufacturing date is unknown. The date entered is the date abbott diabetes care became aware of the event. All pertinent information available to abbott diabetes care has been submitted.
 
Event Description
A healthcare professional reported that a freestyle libre pro sensor filament may have remained in patient of study after sensor removal. It was indicated that patient required treatment by healthcare professional, but no other information was provided. There was no report of death or permanent injury associated with this event.
 
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Brand NameFREESTYLE LIBRE PRO
Type of DeviceFLASH GLUCOSE MONITORING SYSTEM
Manufacturer (Section D)
ABBOTT DIABETES CARE INC
1360 south loop road
alameda CA 94502 7001
Manufacturer Contact
audra fuentes
1360 south loop road
alameda, CA 94502-7001
5107495297
MDR Report Key11097806
MDR Text Key224511703
Report Number2954323-2020-14656
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
PMA/PMN Number
P150021
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 04/01/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/30/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/30/2021
Device Model Number71562-01
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/01/2021
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/26/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/04/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 12/30/2020 Patient Sequence Number: 1
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