BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFTCLIX LANCET DEVICE

    MDR report key: 1772054 · Received November 1, 2007

    Report

    Report Number
    1823260-2007-09526
    Event Type
    Malfunction
    Date Received
    November 1, 2007
    Date of Event
    October 17, 2007
    Report Date
    November 1, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FMK
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER ALLEGED THE LANCET NEEDLE DID NOT RETRACT AFTER FIRING IN THE SOFTCLIX. THE CUSTOMER REPORTED NO ACCIDENTAL STICKS. A REQUEST WAS MADE FOR THE RETURN OF THE SUSPECT DEVICE AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFTCLIX LANCET DEVICE LANCET DEVICE - FMK FMK ROCHE DIAGNOSTICS WIR170

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR NOVOLOG 4 UNITS AM - 5 UNITS NOON, 6 UNITS| LANTUS 18 UNITS AT BEDTIME