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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); Device Displays Incorrect Message (2591)
Patient Problems Hot Flashes/Flushes (2153); Dizziness (2194); Loss of consciousness (2418); Confusion/ Disorientation (2553)
Event Date 07/11/2022
Event Type  Injury  
Event Description
A customer reported receiving a sensor error message from the adc device.The customer became confused with symptoms of feeling flush, dizziness, and lost consciousness.The customer was unable to self-treat, however, no third-party intervention was reported.There was no report of death or permanent injury associated with this event.
 
Manufacturer Narrative
Sensor (b)(4) has been returned and investigated.Visual inspection has been performed on sensor and no issues were observed.The sensor plug was seated in mount properly.Extracted data from returned sensor using approved software.Sensor found to be in state 5 (indicating normal termination).Removed the sensor plug and inspected the plug assembly, no failure mode observed.The current was applied to the sensor to perform linearity testing while in the test fixture.All results were within specification.All results were within specification.No malfunction or product deficiency was identified.All pertinent information available to abbott diabetes care has been submitted.
 
Manufacturer Narrative
Sensor (b)(6) has been returned and investigated.The sensor plug is fully seated and no issues were observed on the sensor patch.Extracted data from the returned sensor using approved software.The sensor was found to be in sensor state 5 (indicating normal termination).Inspected the plug assembly, no issues were observed.Watermark was observed at the base of the tail.Issue is not confirmed.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 sensor and libre sensor kits were reviewed and the dhrs showed the libre sensor and libre sensor kits 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 npr results.
 
Event Description
A customer reported receiving a sensor error message from the adc device.The customer became confused with symptoms of feeling flush, dizziness, and lost consciousness.The customer was unable to self-treat, however, no third-party intervention 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
Manufacturer Contact
audra fuentes
1360 south loop road
alameda, CA 94502-7001
5107495297
MDR Report Key15656707
MDR Text Key302250629
Report Number2954323-2022-39031
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
Report Date 11/09/2023
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 Expiration Date09/30/2023
Device Model Number71992-01
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/05/2022
Initial Date Manufacturer Received 09/27/2022
Initial Date FDA Received10/23/2022
Supplement Dates Manufacturer Received11/09/2023
Supplement Dates FDA Received11/09/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/23/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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