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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 01/25/2023
Event Type  Injury  
Event Description
A customer reported being unable to test using the adc device due to the test not starting upon sample application.The customer experienced "deep sleep" and was given orange juice by a third-party for treatment.There was no report of death or permanent injury associated with this event.
 
Manufacturer Narrative
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.Dhrs for the freestyle freedom lite meter and freestyle freedom lite strips were reviewed and the dhrs showed the freestyle freedom lite meter 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.
 
Manufacturer Narrative
Reader (b)(6).Has been returned and investigated.Visual inspection was performed on the returned reader and no issues were observed.Attempted to perform control solution testing.Test did not fire.De-cased reader and performed visual inspection and observed liquid contamination.Therefore, issue is not confirmed to use.All pertinent information available to abbott diabetes care has been submitted.
 
Event Description
A customer reported being unable to test using the adc device due to the test not starting upon sample application.The customer experienced "deep sleep" and was given orange juice by a third-party for treatment.There was no report of death or permanent injury associated with this event.
 
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.The dhrs (device history record) for the fs libre reader were reviewed, and the dhrs showed the fs 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.This serves as a correction report.Section h-10 was incorrectly documented in the initial report.
 
Event Description
A customer reported being unable to test using the adc device due to the test not starting upon sample application.The customer experienced "deep sleep" and was given orange juice by a third-party for treatment.There was no report of death or permanent injury 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 Key16404880
MDR Text Key309859472
Report Number2954323-2023-07451
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 02/13/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
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
Initial Date Manufacturer Received 01/30/2023
Initial Date FDA Received02/20/2023
Supplement Dates Manufacturer Received02/26/2023
Supplement Dates FDA Received03/16/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/14/2022
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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