BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBRE 2 SENSOR FREESTYLE

    MDR report key: 13094468 · Received December 28, 2021

    Report

    Report Number
    2954323-2021-97149
    Event Type
    Malfunction
    Date Received
    December 28, 2021
    Date of Event
    December 20, 2021
    Report Date
    February 9, 2022
    Manufacturer
    ABBOTT DIABETES CARE INC
    Product Code
    QLG
    PMA / PMN Number
    K193371
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    SENSOR 3MH0089C11R 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). INSPECTED THE PLUG ASSEMBLY, NO ISSUES WERE OBSERVED. REPROGRAMMED AND ATTEMPTED TO ACTIVATE THE SENSOR AND SENSOR STATE WENT BACK TO 6. AN EXTENDED INVESTIGATION WAS ALSO PERFORMED ON THE RETURNED DE-CASED SENSOR AND CORROSION WAS OBSERVED ON PCBA (PRINTED CIRCUIT BOARD ASSEMBLY) AND BATTERY HOUSING. ATTEMPTED TO REPROGRAM RETURNED SENSOR, UNABLE TO ACTIVATE RETURNED SENSOR OBSERVED ERROR TERMINATION STATE. PQE CLEANED THE PCBA AND ATTEMPTED TO REMOVE CORROSION AND PERFORM LINEARITY TEST, PQE WAS STILL UNABLE TO ACTIVATE RETURNED SENSOR. PQE ALSO REPLACED RETURNED BATTERY WITH A KNOWN GOOD BUT WAS STILL UNABLE TO ACTIVATE RETURNED SENSOR. PQE BEING UNABLE TO TEST RETURNED SENSOR. THEREFORE, THE ISSUE IS NOT CONFIRMED. 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.

    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
    1993237 LIBRE 2 SENSOR FREESTYLE FLASH GLUCOSE MONITORING SYSTEM QLG ABBOTT DIABETES CARE INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown