BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFTCLIX ® PLUS LANCET DEVICE

    MDR report key: 3013654 · Received March 20, 2013

    Report

    Report Number
    1823260-2013-01711
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Date of Event
    February 25, 2013
    Report Date
    May 22, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FMK
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6). THE YEAR IS THE ONLY KNOWN PART OF MANUFACTURE DATE. WE HAVE DEFAULTED TO THE FIRST OF THE YEAR.

    Description of Event or Problem · 1

    REPORTER STATED LANCET PROTRUDES BEYOND THE END CAP OF THE SOFTCLIX PLUS DEVICE. NO ACCIDENTAL STICK OCCURRED. NO ADVERSE EVENT REPORTED. CUSTOMER DID NOT PROVIDE THE LOT NUMBER OF THE LANCETS. THE MANUFACTURER REQUESTED RETURN OF SUSPECT PRODUCT FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116393 SOFTCLIX ® PLUS LANCET DEVICE LANCET DEVICE FMK ROCHE DIAGNOSTICS NA BAT019

    Patients

    Seq Age Sex Outcome Treatment
    1 050 YR