BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFTCLIX LANCET DEVICE

    MDR report key: 1780368 · Received September 12, 2007

    Report

    Report Number
    1823260-2007-08099
    Event Type
    Malfunction
    Date Received
    September 12, 2007
    Date of Event
    August 1, 2007
    Report Date
    September 14, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FMK
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 LANCET DEVICE. NO ACCIDENTAL STICKS WERE REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE SUSPECT DEVICE AND 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 BAT037

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR NOVOLOG - 4 MONTHS - 6-12UNITS THRICE DAILY| TRILEPTAL - 1 YEAR - DOSAGE UNK - TWICE DAILY| LANTUS - 4 MONTHS - 18UNITS DAILY| "CASERTA" - 1 YEAR - DOSAGE UNK - ONCE DAILY