BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® MULTICLIX

    MDR report key: 1852318 · Received October 4, 2010

    Report

    Report Number
    1823260-2010-05865
    Event Type
    Malfunction
    Date Received
    October 4, 2010
    Date of Event
    September 26, 2010
    Report Date
    October 14, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FMK
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    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 THAT DURING A POUCH PROCEDURE, THE VERY SKILLED SURGEON COULD NOT ATTACH THE HEAD TO THE STAPLER. THEY OPENED A NEW STAPLER AND SUCCEEDED TO ATTACH THE HEAD TO THIS ONE, WHICH DID NOT SEEM TO HAVE THE RESISTANCE WITH THIS RETURNED DEVICE. SURGERY WAS PROLONGED 10 MINUTES. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Description of Event or Problem · 1

    CALLER REPORTS LANCET IS PROTRUDING FROM MULTICLIX DEVICE CAP. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE PRODUCT, REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ® MULTICLIX LANCET DEVICE FMK ROCHE DIAGNOSTICS NA GWU074

    Patients

    Seq Age Sex Outcome Treatment
    1