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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC LIBRE 2 SENSOR FREESTYLE; FLASH GLUCOSE MONITORING SYSTEM
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ABBOTT DIABETES CARE INC LIBRE 2 SENSOR FREESTYLE; FLASH GLUCOSE MONITORING SYSTEM Back to Search Results
Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/17/2020
Event Type  malfunction  
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 fs libre sensor and fs libre sensor kit were reviewed and the dhrs showed the fs libre sensor and sensor kit 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 receiving erroneous glucose results from an abbott diabetes care device.The results when plotted on a parkes error grid fell into either the c, d, or e zone.There was no report of death, serious injury, or mistreatment associated with this event.
 
Manufacturer Narrative
Sensor (b)(6) has been returned and investigated.The sensor plug is fully seated and no issues were observed.Extracted data from the returned sensor using approved software.The sensor was found to be in sensor state 6 (indicating early termination).Observed patch terminated on body.The sensor was reprogrammed and attempted to active the sensor with evm (evaluation module) and sensor state went back to 6 (indicating early termination).Extended investigation has been performed the sensor was de-cased and observed liquid contamination on the pcb.Replaced the battery with a known good battery.The sensor was reprogrammed and activated with evm to perform linearity test.Inspected the plug assembly, no issues were observed.The current was applied to the sensor to perform linearity testing while in the test fixture.All results were within specification.No malfunction or product deficiency was identified.Dspc-20a issue was already linked.All pertinent information available to abbott diabetes care has been submitted.
 
Event Description
A customer reported receiving erroneous glucose results from an abbott diabetes care device.The results when plotted on a parkes error grid fell into either the c, d, or e zone.There was no report of death, serious injury, or mistreatment associated with this event.
 
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Brand Name
LIBRE 2 SENSOR FREESTYLE
Type of Device
FLASH GLUCOSE MONITORING SYSTEM
Manufacturer (Section D)
ABBOTT DIABETES CARE INC
1360 south loop road
alameda CA 94502 7001
MDR Report Key11071225
MDR Text Key223603229
Report Number2954323-2020-14380
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 04/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/24/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date06/30/2021
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/05/2021
Date Manufacturer Received04/13/2021
Is This a Reprocessed and Reused Single-Use Device? Yes
Patient Sequence Number1
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