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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT DIABETES CARE LTD LIBRE 3 SENSOR FREESTYLE; CONTINUOUS GLUCOSE MONITORING SYSTEM
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ABBOTT DIABETES CARE LTD LIBRE 3 SENSOR FREESTYLE; CONTINUOUS GLUCOSE MONITORING SYSTEM Back to Search Results
Model Number 72081-01
Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/14/2022
Event Type  malfunction  
Manufacturer Narrative
Repeated attempts by adc to retrieve the product were unsuccessful and/or the customer discarded the product.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.N/a was selected for pma/510k as it is unknown if the user was using android, ios, or a fs libre reader with the fs libre 3 sensor.
 
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.Visual inspection performed on the returned sensor patch and no issue was observed.Data was extracted using approved software and extraction was successful.Sensor state 7 with event log 11 and sensor state 8 with event log 9 are an indication that the sensor had terminated due to an error recognized by the sensor.This is a part of software design and is not an indication of product non-conformance.Smu (source measurement unit) test will be performed on the sensor to verify if sensor is functioning as intended.The watermark was observed at the base of the tail indicating the sensor being properly inserted.Sensor was damaged during de-casing.An extended investigation was performed.Visual inspection has been performed on returned de-cased sensor and observed glue over the poise voltage test points.Poise voltage test was performed using connector key and results were within specification.Passing all smu (source measurement unit) test indicates that there were no issues with sensor functionality and electronics.Sensor thermistor testing was within specification, indicating the sensor was providing accurate glucose readings.Performed poise voltage test for the returned sensor and all results were within specification.All test results were within specification.During testing, no abnormal errors were observed indicating that the error termination was not caused by sensor malfunction.As no indication of a sensor defect was discovered during the investigation, the error termination had no effect on the functionality of the sensor.The passing of functionality testing indicates that there were no problems with sensor functionality and electronics.Therefore, this issue is not confirmed.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 3 SENSOR FREESTYLE
Type of Device
CONTINUOUS GLUCOSE MONITORING SYSTEM
Manufacturer (Section D)
ABBOTT DIABETES CARE LTD
range road
witney 12345 -700
UK  12345-7001
Manufacturer Contact
audra fuentes
1360 south loop road
alameda, CA 94502-7001
5107495297
MDR Report Key16076289
MDR Text Key308209715
Report Number2954323-2022-47584
Device Sequence Number1
Product Code QLG
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
N/A
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 01/11/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date09/30/2023
Device Model Number72081-01
Was Device Available for Evaluation? Device Returned to Manufacturer
Initial Date Manufacturer Received 12/14/2022
Initial Date FDA Received12/30/2022
Supplement Dates Manufacturer Received01/09/2024
Supplement Dates FDA Received01/11/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/16/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? Yes
Patient Sequence Number1
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