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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 71992-01
Device Problems Unable to Obtain Readings (1516); Device Displays Incorrect Message (2591)
Patient Problems Hypoglycemia (1912); Hot Flashes/Flushes (2153); Cognitive Changes (2551); Confusion/ Disorientation (2553)
Event Date 10/13/2023
Event Type  Injury  
Manufacturer Narrative
The product has been requested back for an investigation.At this time product has not yet been returned.An extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.The device history records (dhrs) for the freestyle libre sensor and freestyle libre sensor kit were reviewed and the dhrs showed the freestyle libre sensor and sensor kit passed all tests prior to release.If the product is returned, a physical investigation will be performed and a follow-up report submitted.All pertinent information available to abbott diabetes care has been submitted.
 
Event Description
A replace sensor error message was reported with the adc device and customer was unable to obtain readings.As a result, customer experienced confusion, feeling reported as ¿hot¿ and was unable to self-treat, requiring third-party administration of glucose, gel (unspecified) and diafoxyde for treatment.There was no report of death or permanent impairment associated with this event.
 
Manufacturer Narrative
Sensor (b)(6) has been returned and investigated.The sensor plug was properly seated, and no physical damage was observed on the returned sensor patch.Data was extracted from the returned sensor patch using approved software.The sensor was found to be in sensor state 6 (indicating abnormal termination) with a brownout reset event internally logged (event 21).Visual inspection was performed on the sensor plug and no failure modes were observed.The returned sensor was sent for further investigation and de-cased.Visual inspection was performed on the pcba (printed circuit board assembly) and no issues were observed.An extended investigation has also been performed on the returned puck and no issues were observed.The battery was measured, and the results were within specification.Therefore, this issue is confirmed to brownout reset.All pertinent information available to abbott diabetes care has been submitted.
 
Event Description
A replace sensor error message was reported with the adc device and customer was unable to obtain readings.As a result, customer experienced confusion, feeling reported as ¿hot¿ and was unable to self-treat, requiring third-party administration of glucose, gel (unspecified) and diafoxyde for treatment.There was no report of death or permanent impairment 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 Key17996390
MDR Text Key326390393
Report Number2954323-2023-46992
Device Sequence Number1
Product Code QLG
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K193371
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 11/21/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/24/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model Number71992-01
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Manufacturer Received10/26/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/26/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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