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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 No Device Output (1435); Unable to Obtain Readings (1516)
Patient Problem Hypoglycemia (1912)
Event Date 05/25/2021
Event Type  Injury  
Manufacturer Narrative
At this time product has not yet been returned.An extended investigation has been performed for the reported complaint and it has been determined that there was no indication that the product did not meet specification.Dhrs (device history record) for the libre reader were reviewed and the dhrs showed the libre reader 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 customer reported that when she applied a blood sample to the test strip of the freestyle libre 2 reader, the test would not start and was therefore unable to obtain readings.Customer experienced symptoms of hypoglycemia and was unable to self-treat, requiring unspecified treatment from a third-party.No further information was provided.There was no report of death or permanent injury associated with this event.
 
Event Description
A customer reported that when she applied a blood sample to the test strip of the freestyle libre 2 reader, the test would not start and was therefore unable to obtain readings.Customer experienced symptoms of hypoglycemia and was unable to self-treat, requiring unspecified treatment from a third-party.No further information was provided.There was no report of death or permanent injury associated with this event.
 
Manufacturer Narrative
The reported reader was returned and investigated with known good strips.Visual inspection was performed on the returned reader and no issues were observed.The reader did not turn on with known good strip insertion.The reader was sent for further investigation.The reader was de-cased, and a red dot was observed on the inside of the case which indicates liquid ingress.Therefore, the issue is not confirmed due to use.
 
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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
MDR Report Key12063120
MDR Text Key258363851
Report Number2954323-2021-73639
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 09/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/24/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model Number71953-01
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/13/2021
Date Manufacturer Received08/26/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age64 YR
Patient Weight55
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