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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 Device Alarm System (1012)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 06/13/2021
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 kits 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 caller reported "an unexpected alarm" while using the adc freestyle libre 2 reader.On (b)(6) 2021, as a result, the customer experienced being restless, tired, exhausted, and was unable to treat themselves.The customer was provided unspecified treatment by a non-hcp.No further information was provided.There was no report of death or permanent injury associated with this event.
 
Event Description
A caller reported "an unexpected alarm" while using the adc freestyle libre 2 reader.On (b)(6) 2021, as a result, the customer experienced being restless, tired, exhausted, and was unable to treat themselves.The customer was provided unspecified treatment by a non-hcp.No further information was provided.There was no report of death or permanent injury associated with this event.
 
Manufacturer Narrative
Reader (b)(6) has been returned and investigated.Visual inspection was performed on the returned reader and no issues were observed.Analysis of glucose value graph was performed and alarms observed coincided with high/low glucose limits.No malfunction or product deficiency has been identified.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 Key12058396
MDR Text Key258080182
Report Number2954323-2021-73619
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 08/27/2021
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
Date Returned to Manufacturer07/09/2021
Initial Date Manufacturer Received 06/16/2021
Initial Date FDA Received06/24/2021
Supplement Dates Manufacturer Received08/17/2021
Supplement Dates FDA Received08/27/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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