BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFTCLIX ® PLUS LANCET DEVICE

    MDR report key: 2040248 · Received April 5, 2011

    Report

    Report Number
    1823260-2011-01897
    Event Type
    Malfunction
    Date Received
    April 5, 2011
    Date of Event
    March 27, 2011
    Report Date
    June 2, 2011
    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.

    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 BAV017

    Patients

    Seq Age Sex Outcome Treatment
    1