BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK MULTICLIX

    MDR report key: 1780387 · Received September 14, 2007

    Report

    Report Number
    1823260-2007-08080
    Event Type
    Malfunction
    Date Received
    September 14, 2007
    Date of Event
    August 24, 2007
    Report Date
    September 14, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FMK
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTS NEEDLE DOES NO RETRACT. CUSTOMER STATES LANCET IS PROTRUDING AFTER FIRING WHILE USING THE MULTICLIX LANCET DEVICE. NO ACCIDENTAL STICK REPORTED. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR RETURN OF THE SUSPECT PRODUCT AND A REPLACEMENT WAS SENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR HUMALOG SLIDING SCALE 2X/DAY| LANTUS 55 UNITS 2X/DAY - 5-6 YRS