BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® MULTICLIX

    MDR report key: 2254192 · Received September 19, 2011

    Report

    Report Number
    1823260-2011-04963
    Event Type
    Malfunction
    Date Received
    September 19, 2011
    Date of Event
    August 8, 2011
    Report Date
    November 7, 2011
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    CUSTOMER ORIGINALLY CALLED TO STATE THAT THE LANCET DEVICE IS "MALFUNCTIONING" (SPECIFICS NOT PROVIDED). UPON REVIEW BY THE FIRST LEVEL INVESTIGATION UNIT, IT WAS FOUND THAT THE LANCET PROTRUDED PAST THE END CAP OF THE DEVICE. NO ACCIDENTAL STICK OCCURRED. NO ADVERSE EVENT REPORTED. SUSPECT DEVICE HAS BEEN RETURNED. REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ® MULTICLIX LANCET DEVICE FMK ROCHE DIAGNOSTICS NA WPX026

    Patients

    Seq Age Sex Outcome Treatment
    1