BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFTCLIX LANCET DEVICE

    MDR report key: 1002120 · Received February 20, 2008

    Report

    Report Number
    1823260-2008-01711
    Event Type
    Malfunction
    Date Received
    February 20, 2008
    Date of Event
    May 8, 2007
    Report Date
    February 20, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FMK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED THE NEEDLE FROM THE SOFTCLIX LANCET DEVICE PROTRUDES OUTSIDE THE END OF THE CAP. NO ACTIONS OR TREATMENTS WERE REPORTED. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE SUSPECT DEVICE AND REPLACEMENT PROD WAS SENT. REPORTER STATED THAT THE DEVICE WAS DISCARDED AND SO NO PROD WILL BE RETURNED FOR EVAL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR NOVOLOG - 4 YRS CONTINUOUS PUMP| SYNTHROID - 6 MONTHS 40MG ONCE DAILY