BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFTCLIX® PLUS LANCET DEVICE

    MDR report key: 1841608 · Received September 22, 2010

    Report

    Report Number
    1823260-2010-05626
    Event Type
    Malfunction
    Date Received
    September 22, 2010
    Date of Event
    September 18, 2010
    Report Date
    September 22, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FMK
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CALLER REPORTS LANCET PROTRUDES BEYOND THE END CAP OF THE SOFTCLIX PLUS DEVICE. NO ACCIDENTAL NEEDLE STICK OCCURRED. 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 ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1