BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK MULTICLIX

    MDR report key: 1181323 · Received September 23, 2008

    Report

    Report Number
    1823260-2008-07097
    Event Type
    Malfunction
    Date Received
    September 23, 2008
    Date of Event
    March 20, 2008
    Report Date
    September 23, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FMK
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    CUSTOMER'S WIFE REPORTS LANCET STICKS OUT WHILE USING THE MULTICLIX LANCET DEVICE. WIFE REPORTS CUSTOMER CAN NOT RECALL WHETHER LANCET PROTRUDED BEFORE OR AFTER FIRING. NO ACCIDENTAL STICK REPORTED. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR RETURN OF THE SUSPECT PRODUCT AND A REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK MULTICLIX LANCET DEVICE- FMK FMK ROCHE DIAGNOSTICS WPO8049

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR METFORMIN - 3 OR 4 YEARS