BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFTCLIX ® LANCET DEVICE

    MDR report key: 2945155 · Received February 6, 2013

    Report

    Report Number
    1823260-2013-00691
    Event Type
    Malfunction
    Date Received
    February 6, 2013
    Date of Event
    January 9, 2013
    Report Date
    July 29, 2025
    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
    Health Professional
    N

    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

    CALLER REPORTS LANCET PROTRUDES BEYOND THE END CAP OF THE SOFTCLIX DEVICE. CALLER STATES THE END CAP WOULD NOT STAY ON THE 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
    50465 SOFTCLIX ® LANCET DEVICE LANCET DEVICE FMK ROCHE DIAGNOSTICS NA WIN313

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Male