BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK MULTICLIX

    MDR report key: 1437846 · Received April 24, 2009

    Report

    Report Number
    1823260-2009-02940
    Event Type
    Malfunction
    Date Received
    April 24, 2009
    Date of Event
    March 31, 2009
    Report Date
    April 24, 2009
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FMK
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    UPON INVESTIGATION ON 04/21/2009, MANUFACTURER'S DOMESTIC EVALUATIONS LAB FOUND LANCET DID NOT RETRACT INTO MULTICLIX DEVICE AFTER FIRING, LANCET IS PROTRUDING FROM DEVICE CAP. NO ADVERSE EVENT REPORTED. REPLACEMENT WAS SENT, DEVICE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK MULTICLIX LANCET DEVICE - FMK FMK ROCHE DIAGNOSTICS GWU059

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK