BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK MULTICLIX LANCETS

    MDR report key: 1083497 · Received July 28, 2008

    Report

    Report Number
    1823260-2008-05813
    Event Type
    Injury
    Date Received
    July 28, 2008
    Date of Event
    July 24, 2008
    Report Date
    July 28, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FMK
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED HE VISITED HIS MD BECAUSE OF SORE FINGERS WHILE USING THE MULTICLIX LANCET DEVICE. CUSTOMER REPORTS HE REC'D AN INFECTION; WAS TREATED WITH ANTIBIOTICS. 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 LANCETS LANCET - FMK FMK ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention STARLIX 2 YEARS