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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 Problem Image Display Error/Artifact (1304)
Patient Problems Hypoglycemia (1912); Diaphoresis (2452)
Event Date 02/02/2021
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.The dhrs (device history review) for the libre reader was 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.The date of event 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 customer reported, "bright beams" described as "white wide lines" displayed on the adc freestyle libre 2 reader screen.As a result of not being able to monitor their blood glucose, the customer experienced symptoms of hypoglycemia described as sweating and was provided grape sugar and sweet drinks for a diagnosis of hypoglycemia.There was no report of death or permanent injury associated with this event.
 
Event Description
A customer reported, "bright beams" described as "white wide lines" displayed on the adc freestyle libre 2 reader screen.As a result of not being able to monitor their blood glucose, the customer experienced symptoms of hypoglycemia described as sweating and was provided grape sugar and sweet drinks for a diagnosis of hypoglycemia.There was no report of death or permanent injury associated with this event.
 
Manufacturer Narrative
The reported reader (b)(6) was returned and investigated.Visual inspection was performed on the returned reader and no issues were observed.The reader was turned on and a cracked display caused by misuse was observed.The reader log was downloaded and observed readings in the log, proving this is not an out of the box issue.Therefore, this issue is not confirmed to use.All pertinent information available to abbott diabetes care has been submitted.
 
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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 Key11305147
MDR Text Key231121481
Report Number2954323-2021-03419
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 07/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/09/2021
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 Manufacturer06/04/2021
Date Manufacturer Received07/05/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age76 YR
Patient Weight100
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