BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFTCLIX PLUS LANCET DEVICE

    MDR report key: 1771972 · Received September 18, 2007

    Report

    Report Number
    1823260-2007-08186
    Event Type
    Malfunction
    Date Received
    September 18, 2007
    Date of Event
    September 1, 2007
    Report Date
    September 18, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FMK
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTS LANCET WILL NOT RETRACT BACK INTO THE SOFTCLIX PLUS DEVICE AFTER FIRING, RESULTING IN AN ACCIDENTAL NEEDLE STICK (NO MEDICAL TREATMENT REQUIRED). NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFTCLIX PLUS LANCET DEVICE LANCET DEVICE - FMK FMK ROCHE DIAGNOSTICS BAT045

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR LEVOXYL - 100 MCG IN AM - 5 YEARS| PRIMIDONE - 50 MG IN AM - 4 YEARS| NOVOLOG FLEX PEN 70/30 - 2 YEARS 12 UNITS AM| NOVOLOG FLEX PEN 70/30 - 2 YEARS 14 UNITS PM| BENICAR - 12.5 MG IN AM - 2 YEARS