BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFTCLIX® LANCET DEVICE

    MDR report key: 1823777 · Received September 2, 2010

    Report

    Report Number
    1823260-2010-05215
    Event Type
    Malfunction
    Date Received
    September 2, 2010
    Date of Event
    August 30, 2010
    Report Date
    September 10, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FMK
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Additional Manufacturer Narrative · 1

    DEVICE RECEIVED IN A CONDITION WHICH MADE ANALYSIS IMPOSSIBLE. UNABLE TO FIRE DEVICE DUE TO A DEFECTIVE BUTTON. COULD NOT TEST TO SEE IF THE LANCET RETRACTED.

    Description of Event or Problem · 1

    CALLER STATES THIS INFORM METER WAS REPORTED BY THE OPERATORS TO BE SMOKING AND MELTED WHEN DOCKED. THE ELECTRICAL CONTACTS OF THE INFORM METER ARE BLACKENED AND THE PLASTIC AROUND THEM IS MELTED. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF DEVICE, REPLACEMENT WAS SENT.

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFTCLIX® LANCET DEVICE LANCET DEVICE FMK ROCHE DIAGNOSTICS NA WIL029

    Patients

    Seq Age Sex Outcome Treatment
    1