BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK MULTICLIX

    MDR report key: 1083913 · Received July 28, 2008

    Report

    Report Number
    1823260-2008-05802
    Event Type
    Malfunction
    Date Received
    July 28, 2008
    Date of Event
    July 24, 2008
    Report Date
    July 28, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FMK
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CALLER STATES THE LANCET DOES NOT RETRACT INTO THE MUTLICLIX 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 WIT098

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR HUMALOG DATES UNK| LANTUS 30 UNITS/DAY