BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK MULTICLIX

    MDR report key: 1053159 · Received May 27, 2008

    Report

    Report Number
    1823260-2008-04317
    Event Type
    Injury
    Date Received
    May 27, 2008
    Date of Event
    January 23, 2008
    Report Date
    May 27, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FMK
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTS SHE HAD TO SEEK MEDICAL TREATMENT FOR SORE FINGERS WHILE USING THE MULTICLIX LANCET DEVICE. CUSTOMER REPORTS SHE WENT TO THE DR. AND RECEIVED TREATMENT IN THE FORM OF IODINE AND AN ANTIBIOTIC CREAM. CUSTOMER STATES HER FINGERS ARE FINE NOW. 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 35 YR Required Intervention GLUCOPHAGE| GLUCOTROL