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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 Display or Visual Feedback Problem (1184); Unable to Obtain Readings (1516)
Patient Problem Loss of consciousness (2418)
Event Date 03/05/2021
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 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 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 the adc freestyle libre 2 reader touchscreen does not respond when pressed.On (b)(6) 2021, as a result, the customer had a loss of consciousness and was provided insulin (dosage unknown) by the hcp for treatment.Please note the treatment of insulin is not consistent with the customer's 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.Performed visual inspection on returned reader an no issues were observed.A touchscreen test was performed and observed the touchscreen responded properly.No malfunction or product deficiency was identified.Therefore, the issue is not confirmed.All pertinent information available to abbott diabetes care has been submitted.
 
Event Description
A customer reported the adc freestyle libre 2 reader touchscreen does not respond when pressed.On (b)(6) 2021, as a result, the customer had a loss of consciousness and was provided insulin (dosage unknown) by the hcp for treatment.Please note the treatment of insulin is not consistent with the customer's diagnosis of hypoglycemia.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 Key11485497
MDR Text Key239799530
Report Number2954323-2021-35881
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 07/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/15/2021
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 Manufacturer04/09/2021
Date Manufacturer Received07/14/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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