BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFTCLIX ® PLUS LANCET DEVICE

    MDR report key: 2042122 · Received April 6, 2011

    Report

    Report Number
    1823260-2011-01912
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    March 30, 2011
    Report Date
    June 14, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FMK
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CALLER REPORTS LANCET PROTRUDES BEYOND THE END CAP OF THE SOFTCLIX PLUS DEVICE. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE DEVICE AND LANCETS, 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 BAW016

    Patients

    Seq Age Sex Outcome Treatment
    1