BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® MULTICLIX

    MDR report key: 1902600 · Received November 18, 2010

    Report

    Report Number
    1823260-2010-06828
    Event Type
    Malfunction
    Date Received
    November 18, 2010
    Date of Event
    November 12, 2010
    Report Date
    January 11, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FMK
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED BY SERVICE REPORT THAT THE FOOT END LIFT WAS LEAKING FLUID ONTO THE FLOOR. NO PATIENT WAS INVOLVED AND NO ADVERSE CONSEQUENCES WERE REPORTED.

    Description of Event or Problem · 1

    CALLER REPORTS LANCET PROTRUDES BEYOND THE END CAP OF THE MULTICLIX DEVICE. NO ACCIDENTAL NEEDLE 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 GWX013

    Patients

    Seq Age Sex Outcome Treatment
    1