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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 No Device Output (1435); Unable to Obtain Readings (1516)
Patient Problem Hypoglycemia (1912)
Event Date 12/21/2022
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 freedom lite meter and freestyle freedom lite strips were reviewed and the dhrs showed the freestyle freedom lite meter 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 being unable to test using the adc device due to the test not starting upon sample application.The customer experienced symptoms described as "pale, slow talking, and feeling bad".The customer was treated with soda and candy by a third-party.There was no report of death or permanent injury associated with this event.
 
Event Description
A customer reported being unable to test using the adc device due to the test not starting upon sample application.The customer experienced symptoms described as "pale, slow talking, and feeling bad." the customer was treated with soda and candy by a third-party.There was no report of death or permanent injury associated with this event.
 
Manufacturer Narrative
The reported meter (b)(6) was returned and investigated.Visual inspection was performed on the returned reader and damaged usb port was observed.The damaged usb port would prevent the customer from charging the reader which would lead to the reader not turning on.The returned reader was de-cased and placed into the reader test fixture to download log.Issue is not confirmed to use.All pertinent information available to abbott diabetes care has been submitted.
 
Manufacturer Narrative
The reported meter (b)(6) was returned and investigated.Visual inspection was performed on the returned reader and damaged usb port was observed.The damaged usb port would prevent the customer from charging the reader which would lead to the reader not turning on.The returned reader was de-cased and placed into the reader test fixture to download log.Issue is not confirmed to use.An extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.Dhrs (device history record) for the libre reader were reviewed and the dhrs showed the libre reader passed all tests prior to release.All pertinent information available to abbott diabetes care has been submitted.This serves as a correction report.Section h10 has been updated to include the correct investigation results.
 
Event Description
A customer reported being unable to test using the adc device due to the test not starting upon sample application.The customer experienced symptoms described as "pale, slow talking, and feeling bad." the customer was treated with soda and candy by a third-party.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
Manufacturer Contact
audra fuentes
1360 south loop road
alameda, CA 94502-7001
5107495297
MDR Report Key16195256
MDR Text Key307593143
Report Number2954323-2023-03003
Device Sequence Number1
Product Code QLG
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K193371
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup,Followup
Report Date 03/08/2024
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
Initial Date Manufacturer Received 12/21/2022
Initial Date FDA Received01/18/2023
Supplement Dates Manufacturer Received03/09/2023
03/08/2024
Supplement Dates FDA Received03/29/2023
03/08/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/03/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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