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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 71952-01
Device Problem Power Problem (3010)
Patient Problem Hyperglycemia (1905)
Event Date 02/05/2021
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 there was no indication that the product did not meet specification.Dhrs for the freestyle libre reader was reviewed and the dhrs showed the freestyle libre reader passed all tests prior to release.If the product is returned, the case will be re-opened and a physical investigation will be performed.All pertinent information available to abbott diabetes care has been submitted.
 
Event Description
The customer reported that the adc freestyle libre reader would not turn-on when the button was pressed and he could not monitor his blood glucose.A blood glucose reading of 24.4 mmol/l was obtained on an unspecified device and the emergency doctor was called and insulin (dose unknown) was administered as treatment.No further treatment was reported.There was no report of death or permanent injury associated with this event.
 
Manufacturer Narrative
The reported reader was returned and investigated.Performed visual inspection on returned reader an no issues were observed.Reader turns on when pressing the start button.No malfunction or product deficiency was identified.Therefore, the issue is not confirmed.
 
Event Description
The customer reported that the adc freestyle libre reader would not turn-on when the button was pressed and he could not monitor his blood glucose.A blood glucose reading of 24.4 mmol/l was obtained on an unspecified device and the emergency doctor was called and insulin (dose unknown) was administered as treatment.No further treatment was reported.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
MDR Report Key11361068
MDR Text Key233036889
Report Number2954323-2021-04758
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 07/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/22/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model Number71952-01
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/12/2021
Date Manufacturer Received07/14/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age51 YR
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