BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFTCLIX LANCET DEVICE

    MDR report key: 1780535 · Received September 19, 2007

    Report

    Report Number
    1823260-2007-08204
    Event Type
    Malfunction
    Date Received
    September 19, 2007
    Date of Event
    September 1, 2007
    Report Date
    September 19, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FMK
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTS LANCET STICKS OUT AFTER BEING FIRED WHILE USING THE SOFTCLIX LANCET DEVICE. 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 SOFTCLIX LANCET DEVICE LANCET DEVICE - FMK FMK ROCHE DIAGNOSTICS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR HUMULIN INSULIN - 24 UNITS/AM - 30YRS| HUMULIN INSULIN - 10 UNITS/PM - 30YRS