BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK FASTCLIX

    MDR report key: 12094452 · Received June 30, 2021

    Report

    Report Number
    3011393376-2021-01998
    Event Type
    Malfunction
    Date Received
    June 30, 2021
    Date of Event
    June 21, 2021
    Report Date
    August 6, 2021
    Manufacturer
    ROCHE DIABETES CARE, INC.
    Product Code
    FMK
    UDI-DI
    00365702481107
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF REPORT: THE YEAR IS THE ONLY KNOWN PART OF MANUFACTURE DATE. WE HAVE DEFAULTED TO THE FIRST OF THE YEAR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LANCET PROTRUDES BEYOND THE END CAP OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    988420 ACCU-CHEK FASTCLIX LANCET DEVICE FMK ROCHE DIABETES CARE, INC. 05864666160 33319236 00365702481107

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR