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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC FREESTYLE LIBRE 2; FLASH GLUCOSE MONITORING SYSTEM
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ABBOTT DIABETES CARE INC FREESTYLE LIBRE 2; FLASH GLUCOSE MONITORING SYSTEM Back to Search Results
Model Number 71953-01
Device Problems Product Quality Problem (1506); Smoking (1585); Material Deformation (2976)
Patient Problem Insufficient Information (4580)
Event Date 08/31/2020
Event Type  malfunction  
Manufacturer Narrative
No product has been returned and an extended investigation has been performed for the reported complaint.There was no indication that the product did not meet specification.Dhrs (device history review) for the freestyle libre reader were reviewed and the dhrs showed the freestyle libre reader passed all tests prior to release.If product is returned, an investigation will be performed.All pertinent information available to abbott diabetes care has been submitted.
 
Event Description
Customer reported that the could, "see and smell" smoke coming from their freestyle libre reader.Customer further reported that their usb port melted.There was no report of death, serious injury, or mistreatment associated with this event.
 
Manufacturer Narrative
The reported reader ((b)(4)) has been returned and investigated.Visual inspection of the returned reader has been performed and burn marks were observed around the universal serial bus (usb) port.Further investigation has been performed on the returned reader and burn marks were observed on the usb port.The charging cable has not been returned.A power consumption test has been performed on the returned reader, and the results were within specification.Since the current draw from the returned reader was within specification, the reader did not have enough power to cause the reported damage.Therefore, this issue is not confirmed as the reader was functioning as intended.(contact office first name, contact office last name, contact office phone number, and contact office email) has been updated.All pertinent information available to abbott diabetes care has been submitted.
 
Event Description
Customer reported that the could, "see and smell" smoke coming from their freestyle libre reader.Customer further reported that their usb port melted.There was no report of death, serious injury, or mistreatment associated with this event.
 
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Brand Name
FREESTYLE LIBRE 2
Type of Device
FLASH 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 Key10843419
MDR Text Key217699571
Report Number2954323-2020-10843
Device Sequence Number1
Product Code QLG
Combination Product (y/n)N
PMA/PMN Number
K193371
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup
Report Date 06/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/16/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number71953-01
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/25/2020
Date Manufacturer Received05/11/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/24/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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