BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® MULTICLIX

    MDR report key: 3103331 · Received May 9, 2013

    Report

    Report Number
    1823260-2013-02865
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    February 12, 2013
    Report Date
    May 9, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FMK
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. ABSENT THE DEVICE LOT NUMBER, MANUFACTURE DATE CANNOT BE DETERMINED. DEVICE NOT AVAILABLE FOR RETURN

    Description of Event or Problem · 1

    CALLER REPORTED LANCET PROTRUDING FROM MULTICLIX LANCING DEVICE CAP. NO ADVERSE EVENT REPORTED. DEVICE NOT AVAILABLE FOR RETURN, REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203839 ACCU-CHEK ® MULTICLIX LANCET DEVICE FMK ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1