BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFTCLIX ® PLUS GT LANCET DEVICE

    MDR report key: 3103109 · Received May 9, 2013

    Report

    Report Number
    1823260-2013-02855
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    April 12, 2013
    Report Date
    June 14, 2013
    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

    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 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
    204271 SOFTCLIX ® PLUS GT LANCET DEVICE LANCET DEVICE FMK ROCHE DIAGNOSTICS NA BAX008

    Patients

    Seq Age Sex Outcome Treatment
    1