BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® MULTICLIX

    MDR report key: 2211263 · Received August 15, 2011

    Report

    Report Number
    1823260-2011-04344
    Event Type
    Malfunction
    Date Received
    August 15, 2011
    Date of Event
    July 10, 2011
    Report Date
    September 28, 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 DUE TO THE LACK OF PUNCTURING FINGER FROM THE DEVICE. UPON REVIEW BY THE FIRST LEVEL INVESTIGATION UNIT, IT WAS FOUND THAT THE LANCET PROTRUDES BEYOND THE END CAP OF THE MULTICLIX DEVICE. NO ACCIDENTAL STICK OCCURRED. 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 ROCHE DIAGNOSTICS NA GWX054

    Patients

    Seq Age Sex Outcome Treatment
    1