BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK MULTICLIX

    MDR report key: 1770567 · Received October 25, 2007

    Report

    Report Number
    1823260-2007-09329
    Event Type
    Malfunction
    Date Received
    October 25, 2007
    Date of Event
    October 8, 2007
    Report Date
    October 25, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FMK
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED THE NEEDLE FROM THE MULTICLIX LANCET DEVICE PROTRUDES OUTSIDE THE END OF THE CAP AFTER IT HAS BEEN FIRED. NO ACTIONS OR TREATMENTS WERE REPORTED. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE SUSPECT DEVICE AND REPLACEMENT PRODUCT WAS SENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR ZYRTEC, YEAR - 10 MG ONCE DAILY| REQUIP, 1 YEAR - 2 MG ONCE DAILY| PAXIL, 1 YEAR - 125 MG ONCE DAILY| AUGMENTIN, 1 WEEK - 875 MG TWICE DAILY| PRILOSEC, 5 DAYS - 20 MG ONCE DAILY| ALBUTEROL, 1 YEAR - 90 2 PUFFS TWICE DAILY| ADVAIR, 1 YEAR - 250/50 MG TWICE DAILY| PERCOCET, 5 DAYS - 5/325 MG EVERY 4 HRS AS NEEDED| MOTRIN, 5 DAYS - 400 MG THREE TIMES DAILY| ACTOS PLUS, 2 YEARS - 15/500 MG TWICE DAILY| HYDROCHLOROTHIAZIDE, 2 WEEKS - 25 MG ONCE DAILY