BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® MULTICLIX

    MDR report key: 1885222 · Received October 28, 2010

    Report

    Report Number
    1823260-2010-06396
    Event Type
    Malfunction
    Date Received
    October 28, 2010
    Date of Event
    October 18, 2010
    Report Date
    December 13, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FMK
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH SYNCOPE AND THAT THERE WAS INTERMITTENT LOSS OF CAPTURE OBSERVED ALONG WITH NO PACING AND IT WAS SUSPECTED THAT THE LEAD WAS FRACTURED. THERE WAS BLOOD OBSERVED IN THE HEADER OF THE DEVICE. THE LEAD WAS DIFFICULT TO DISCONNECT FROM THE DEVICE. THE DEVICE WAS EXPLANTED AND REPLACED. THE LEAD WAS CAPPED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ® MULTICLIX LANCET DEVICE FMK ROCHE DIAGNOSTICS GWX022

    Patients

    Seq Age Sex Outcome Treatment
    1