BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBRE 2 SENSOR FREESTYLE

    MDR report key: 12778067 · Received November 9, 2021

    Report

    Report Number
    2954323-2021-91677
    Event Type
    Malfunction
    Date Received
    November 9, 2021
    Date of Event
    October 20, 2021
    Report Date
    November 9, 2021
    Manufacturer
    ABBOTT DIABETES CARE INC
    Product Code
    QLG
    UDI-DI
    00357599800000
    PMA / PMN Number
    K193371
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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. SENSOR 3MH007W15WH 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 3 (INDICATING THE SENSOR WAS PAIRED WITHIN THE LAST 14 DAYS). INSPECTED THE PLUG ASSEMBLY. CIG ATTEMPTED TO REPROGRAM THE RETURNED PATCH, HOWEVER AN ERROR OCCURRED DURING REPROGRAMMING. AN EXTENDED INVESTIGATION WAS ALSO PERFORMED BY PQE (PRODUCT QUALITY ENGINEERING GROUP) AND CRACKED SENSOR NECK WAS OBSERVED. PQE TRIED TO EXTRACT THE DATA FROM THE RETURNED PUCK AND DEVICE IS NOT COMPATIBLE ERROR MESSAGE WAS OBSERVED. THIS HAPPENS WHEN AN ERROR OR INTERRUPTION OCCURS DURING THE REPROGRAMMING PROCESS. THE SENSOR IS BRICKED. ISSUE IS UNABLE TO TEST. SECTION H6 (INVESTIGATION FINDINGS) CODE 4247 (APPROPRIATE TERM/CODE NOT AVAILABLE) WAS SELECTED, AS ADC WAS UNABLE TO PERFORM FURTHER TESTING ON THE RETURNED DEVICE. 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 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1682175 LIBRE 2 SENSOR FREESTYLE FLASH GLUCOSE MONITORING SYSTEM QLG ABBOTT DIABETES CARE INC 71992-01 00357599800000

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown