BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK MULTICLIX

    MDR report key: 1032677 · Received April 22, 2008

    Report

    Report Number
    1823260-2008-03411
    Event Type
    Malfunction
    Date Received
    April 22, 2008
    Date of Event
    April 21, 2008
    Report Date
    April 22, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FMK
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CALLER STATES THE LANCET DOES NOT RETRACT INTO THE MULTICLIX LANCET DEVICE. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK MULTICLIX LANCET DEVICE - FMK FMK ROCHE DIAGNOSTICS WIT106

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR HYDROCHLOROTHIAZIDE - 25MG/DAY| VERAPAMIL - 120MG/DAY| AMITRIPTYLINE - 25MG/DAY| METFORMIN - 1000MG/DAY