BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE LIBRE 3

    MDR report key: 24740892 · Received March 31, 2026

    Report

    Report Number
    2954323-2026-19474
    Event Type
    Malfunction
    Date Received
    March 31, 2026
    Date of Event
    March 2, 2026
    Report Date
    May 8, 2026
    Manufacturer
    ABBOTT DIABETES CARE LTD
    Product Code
    QLG
    UDI-DI
    05021791002658
    PMA / PMN Number
    K212132
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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. THE WATERMARK WAS OBSERVED AT THE BASE OF THE TAIL INDICATING THE SENSOR BEING PROPERLY INSERTED. 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. FUNCTIONALITY TEST WILL BE PERFORMED ON THE SENSOR TO VERIFY IF SENSOR IS FUNCTIONING AS INTENDED. THE RETURNED SENSOR WAS FURTHER INVESTIGATED AND DE-CASED. PERFORMED AN INTERNAL VISUAL INSPECTION ON THE SENSOR¿S PCBA (PRINTED CIRCUIT BOARD ASSEMBLY); NO ISSUES WERE OBSERVED. ATTEMPTED TO SCAN SENSOR WITH EVM; SENSOR DID NOT SCAN. RESET THE EVM AND SCANNED THE SENSOR AGAIN; SENSOR DID NOT SCAN. ATTEMPTED TO SCAN SENSOR USING FR4 FIXTURE, SENSOR DID NOT SCAN EITHER. UNABLE TO EXTRACT AND ATTACH THE SENSORS SCAN FILE DUE TO THE SENSOR NOT SCANNING WITH EVM. PQE VISUALLY INSPECTED SENSOR AND NO ISSUES WERE OBSERVED. SENSOR WAS DE-CASED IN PHASE 2 PQE VISUALLY INSPECTED PCBA AND OBSERVED HAIRLINE FRACTURES ON THE PCBA. PQE WAS PERFORMED DATA ANALYSIS ON INITIAL SCAN. 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. FUNCTIONALITY TEST WILL BE PERFORMED ON THE SENSOR TO VERIFY IF SENSOR IS FUNCTIONING AS INTENDED. PQE WAS UNABLE TO PERFORM FUNCTIONALITY TESTING DUE THE HAIRLINE FRACTURES. THE HAIRLINE FRACTURE WERE LOCATED AROUND THE ASIC CAUSING A BREAK IN THE TRACK. THE BROKEN TRACKS THEN LEAD TO THE SENSOR NO LONGER SCANNING. THE HAIRLINE FRACTURES WERE CAUSED DURING THE DE-CASING PROCESS WHEN REMOVING THE PCBA FROM THE SENSOR CASING. THEREFORE, ISSUE WILL BE CLOSED TO UNABLE TO TEST AS THE SENSOR NO LONGER SCANS. SECTION H6 (INVESTIGATION FINDINGS) CODE C20 (NO FINDINGS AVAILABLE) AND D15 CAUSE NOT ESTABLISHED WAS SELECTED, AS ADC WAS UNABLE TO PERFORM FURTHER TESTING ON THE RETURNED DEVICE. 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. DHRS (DEVICE HISTORY REVIEW) FOR THE LIBRE SENSOR AND SENSOR KIT WAS REVIEWED AND THE DHRS SHOWED THE LIBRE SENSOR AND SENSOR KIT MET SPECIFICATIONS PRIOR TO RELEASE TO DISTRIBUTION. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    THE CUSTOMER'S PRODUCT HAS BEEN RETURNED FOR INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ALL INVESTIGATION ACTIVITIES ARE COMPLETE. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED RECEIVING ERRONEOUS GLUCOSE RESULTS FROM AN ABBOTT DIABETES CARE DEVICE. THE CUSTOMER RECEIVED SENSOR SCAN RESULTS OF 52.00 MG/DL COMPARED TO READINGS OF 330.00 MG/DL RESPECTIVELY OBTAINED ON A METER AND THE RESULTS, WHEN PLOTTED ON A PARKES ERROR GRID, FALL INTO THE D ZONE, SHOWING THE DIFFERENCE IN VALUES TO BE CLINICALLY SIGNIFICANT. THE LENGTH OF SENSOR WEAR WAS 5 DAYS. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR MISTREATMENT ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED RECEIVING ERRONEOUS GLUCOSE RESULTS FROM AN ABBOTT DIABETES CARE DEVICE. THE CUSTOMER RECEIVED SENSOR SCAN RESULTS OF 52.00 MG/DL COMPARED TO READINGS OF 330.00 MG/DL RESPECTIVELY OBTAINED ON A METER AND THE RESULTS, WHEN PLOTTED ON A PARKES ERROR GRID, FALL INTO THE D ZONE, SHOWING THE DIFFERENCE IN VALUES TO BE CLINICALLY SIGNIFICANT. THE LENGTH OF SENSOR WEAR WAS 5 DAYS. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR MISTREATMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    443700 FREESTYLE LIBRE 3 CONTINUOUS GLUCOSE MONITORING SYSTEM QLG ABBOTT DIABETES CARE LTD 72081-01 05021791002658

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown