BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFTCLIX LANCET DEVICE

    MDR report key: 1770593 · Received October 25, 2007

    Report

    Report Number
    1823260-2007-09325
    Event Type
    Malfunction
    Date Received
    October 25, 2007
    Date of Event
    August 28, 2007
    Report Date
    October 25, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FMK
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED THE NEEDLE FROM THE SOFTCLIX LANCET DEVICE PROTRUDES OUTSIDE THE END OF THE CAP AFTER IT HAS BEEN FIRED. UPON THE DOMESTIC MANUFACTURER'S EVALUATION DEPARTMENT'S INVESTIGATION, IT WAS CONFIRMED THAT THE LANCET WAS NOT RETRACTING AFTER FIRING. IT WAS NOT PROVIDED WHETHER ANY ACTIONS WERE TAKEN AS THE ORIGINAL CUSTOMER DID NOT MAKE THE ALLEGATION. A REQUEST WAS MADE FOR THE RETURN OF THE SUSPECT DEVICE AND A REPLACEMENT PRODUCT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFTCLIX LANCET DEVICE LANCET DEVICE - FMK FMK ROCHE DIAGNOSTICS WIR171

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK MEDICAL PRODUCTS UNK