BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFTCLIX ® PLUS GT LANCET DEVICE

    MDR report key: 3053042 · Received April 11, 2013

    Report

    Report Number
    1823260-2013-02217
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 17, 2013
    Report Date
    May 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
    TN, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. THE YEAR IS THE ONLY KNOWN PART OF MANUFACTURE DATE. WE HAVE DEFAULTED TO THE FIRST OF THE YEAR.

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. ABSENT THE DEVICE LOT NUMBER, MANUFACTURE DATE CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    CALLER REPORTED LANCET PROTRUDING FROM SOFTCLIX PLUS LANCING DEVICE CAP. 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
    155892 SOFTCLIX ® PLUS GT LANCET DEVICE LANCET DEVICE FMK ROCHE DIAGNOSTICS NA BAW004

    Patients

    Seq Age Sex Outcome Treatment
    1