BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK MULTICLIX

    MDR report key: 1140535 · Received August 28, 2008

    Report

    Report Number
    1823260-2008-06516
    Event Type
    Malfunction
    Date Received
    August 28, 2008
    Date of Event
    August 23, 2008
    Report Date
    August 28, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FMK
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    CUSTOMER'S DAUGHTER REPORTS LANCET STICKS OUT AFTER BEING FIRED WHILE USING THE MULTICLIX LANCET DEVICE. CUSTOMER'S DAUGHTER REPORTS CUSTOMER ACCIDENTALLY STUCK HERSELF; NO TREATMENT WAS RECEIVED. 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

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR DIOVAN 1-2 YRS| LCTINEX GRANULES| HUMALOG 1-2 YRS.| NORVASC| FOSAMAX| LANTUS| ASPIRIN| COREG| PROTONIX| LASIX| LIPITOR| ALLOPURINOL