BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFTCLIX LANCET DEVICE

    MDR report key: 1778855 · Received November 19, 2007

    Report

    Report Number
    1823260-2007-10050
    Event Type
    Malfunction
    Date Received
    November 19, 2007
    Date of Event
    October 24, 2007
    Report Date
    November 19, 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

    UPON EVALUATION BY THE MANUFACTURER, IT WAS DISCOVERED THAT THE LANCET WILL NOT RETRACT AFTER FIRING THE ACCU-CHEK SOFTCLIX LANCET DEVICE. THE CUSTOMER WAS ACCIDENTALLY STUCK, BUT DID NOT REQUIRE MEDICAL ATTENTION. THE ACCU-CHEK CUSTOMER CARE SERVICE CENTER SENT NEW DEVICE AND LANCETS TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFTCLIX LANCET DEVICE LANCET DEVICE - FMK FMK ROCHE DIAGNOSTICS WIP046

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK