BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFTCLIX ® LANCET DEVICE

    MDR report key: 4200318 · Received October 24, 2014

    Report

    Report Number
    1823260-2014-08253
    Event Type
    Malfunction
    Date Received
    October 24, 2014
    Date of Event
    October 14, 2014
    Report Date
    July 28, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FMK
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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. WHILE THIS PRODUCT IS NOT SOLD IN THE UNITED STATES, IT IS LIKE OR SIMILAR TO A PRODUCT MARKETED IN THE UNITED STATES.

    Description of Event or Problem · 1

    REPORTER STATED LANCET PROTRUDES BEYOND THE END CAP OF THE SOFTCLIX DEVICE. NO ACCIDENTAL STICK OCCURRED. NO ADVERSE EVENT REPORTED. THE MANUFACTURER REQUESTED RETURN OF SUSPECT PRODUCT FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679970 SOFTCLIX ® LANCET DEVICE LANCET DEVICE FMK ROCHE DIAGNOSTICS NA BAP113

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Male