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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT DIABETES CARE LTD FREESTYLE LIBRE 3; CONTINUOUS GLUCOSE MONITORING SYSTEM
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ABBOTT DIABETES CARE LTD FREESTYLE LIBRE 3; 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 12/16/2022
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.
 
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.
 
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)was returned and investigated.Visual inspection was performed on the returned sensor, no issues were observed.Data was extracted using approved software, and extraction was successful.Low sensor signal was observed.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.Visual inspection on the returned puck was performed and did not observe any evidence of misuse or abnormalities.De-cased the returned puck and observed no issues with its electrical components or sensor flag, indicating there were no obvious hardware issues with the printed circuit board assembly.Smu test was performed for accuracy of the returned puck's readings and observed to have electrical current and temperature values within specification, indicating no accuracy issues were present in the returned puck and that the puck's thermistor was fully functional.Returned puck's poise voltage was checked and observed values within specification, indicating no issues with electrical signal lines integral to the glucose reading process.No abnormalities were observed during testing.The returned puck passed all testing, and no evidence of a product malfunction was observed during the investigation therefore this issue is not confirmed.All pertinent information available to abbott diabetes care has been submitted.Section d4 (serial number) and h4 (device mfg date) were updated based on return product download.Section d4 (serial number) was updated from (b)(6)to (b)(6).Section h4 (device mfg date) was updated from 7/11/2022 to 7/17/2022.
 
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Brand Name
FREESTYLE LIBRE 3
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 Key16076359
MDR Text Key306616123
Report Number2954323-2022-47598
Device Sequence Number1
Product Code QLG
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K213132
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 07/07/2023
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 Date01/31/2023
Device Model Number72081-01
Was Device Available for Evaluation? Device Returned to Manufacturer
Initial Date Manufacturer Received 12/16/2022
Initial Date FDA Received12/30/2022
Supplement Dates Manufacturer Received06/09/2023
Supplement Dates FDA Received07/07/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/17/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? Yes
Patient Sequence Number1
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