BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFTCLIX ® LANCET DEVICE

    MDR report key: 2101084 · Received May 24, 2011

    Report

    Report Number
    1823260-2011-02775
    Event Type
    Malfunction
    Date Received
    May 24, 2011
    Date of Event
    May 3, 2011
    Report Date
    July 6, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FMK
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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 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 ® LANCET DEVICE LANCET DEVICE FMK ROCHE DIAGNOSTICS NA BAV031

    Patients

    Seq Age Sex Outcome Treatment
    1