BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK MULTICLIX

    MDR report key: 1771979 · Received November 1, 2007

    Report

    Report Number
    1823260-2007-09530
    Event Type
    Malfunction
    Date Received
    November 1, 2007
    Date of Event
    October 13, 2007
    Report Date
    November 1, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FMK
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    THE CALLER REPORTS THAT THE LANCET WOULD NOT RETRACT INTO THE ACCU-CHEK MULTICLIX LANCET DEVICE. THE CALLER WAS ACCIDENTALLY STUCK BUT DID NOT REQUIRE MEDICAL INTERVENTION. NO ADVERSE EVENT REPORTED. THE ACCU-CHEK CUSTOMER CARE SERVICE CENTER SENT NEW DEVICE AND LANCETS AND REQUESTED RETURN OF SUSPECT DEVICE AND LANCETS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK MULTICLIX LANCET DEVICE - FMK FMK ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR