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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 71992-01
Device Problems Unable to Obtain Readings (1516); Firing Problem (4011)
Patient Problems Hyperglycemia (1905); Loss of consciousness (2418)
Event Date 06/12/2021
Event Type  Injury  
Manufacturer Narrative
The product has been requested back for an investigation.A follow-up report will be submitted once additional information is obtained.The device mfg date 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
Customer reported attempting to apply an adc freestyle libre 2 sensor and being unsuccessful due to the inserter not firing.As a result of being unable to monitor glucose levels, customer experienced hyperglycemia and feeling unwell and experienced a loss of consciousness.No self-treatment or third-party treatment was reported.There was no report of death or permanent injury associated with this event.
 
Event Description
Customer reported attempting to apply an adc freestyle libre 2 sensor and being unsuccessful due to the inserter not firing.As a result of being unable to monitor glucose levels, customer experienced hyperglycemia and feeling unwell and experienced a loss of consciousness.No self-treatment or third-party treatment was reported.There was no report of death or permanent injury associated with this event.
 
Manufacturer Narrative
No product has been returned and a valid serial number has not been provided.An extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.A tripped trend review was completed for the reported complaint and fs libre sensors, and there were no adverse trends that indicate any potential product-related issues.If the product is returned, the case will be re-opened, and a physical investigation will be performed.The device mfg date is unknown.The date entered in section h4 is the date abbott diabetes care became aware of the event.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 Key12082200
MDR Text Key258846498
Report Number2954323-2021-74027
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 10/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/29/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model Number71992-01
Was Device Available for Evaluation? No
Date Manufacturer Received09/27/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age30 YR
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