BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK MULTICLIX

    MDR report key: 1781065 · Received July 25, 2007

    Report

    Report Number
    1823260-2007-06504
    Event Type
    Malfunction
    Date Received
    July 25, 2007
    Date of Event
    July 17, 2007
    Report Date
    July 25, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FMK
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE LANCET WOULD NOT RETRACT INTO THE ACCU-CHEK MULTICLIX KIT. NO ACCIDENTAL STICK OR ADVERSE EVENT REPORTED. THE ACCU-CHEK CUSTOMER CARE SERVICE CENTER SENT NEW DEVICE AND DRUM. CUSTOMER ADVISED TO RETURN SUSPECT DEVICE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR HUMALOG - SLIDING SCALE PRN - UNK DOSAGE AND| METFORMIN - 500MG/DAY - UNK DURATION| DURATION