BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFTCLIX ® LANCET DEVICE

    MDR report key: 2895244 · Received January 3, 2013

    Report

    Report Number
    1823260-2013-00061
    Event Type
    Malfunction
    Date Received
    January 3, 2013
    Date of Event
    November 26, 2012
    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
    TX, US
    Reporter Occupation
    PATIENT
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    CALLER REPORTS LANCET PROTRUDES BEYOND THE END CAP OF THE SOFTCLIX DEVICE. NO ACCIDENTAL STICK OCCURRED. NO ADVERSE EVENT REPORTED. THIS OCCURRED WITH 2 DIFFERENT BOXES OF LANCETS. CUSTOMER DID NOT PROVIDE THE LOT NUMBER OF 1 BOX OF LANCETS AS THEY HAVE BEEN DISCARDED. REQUESTED RETURN OF SUSPECTED DEVICE AND BOTH BOXES OF LANCETS; HOWEVER, CUSTOMER HAS DISCARDED 1 BOX OF LANCETS. REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2938 SOFTCLIX ® LANCET DEVICE LANCET DEVICE FMK ROCHE DIAGNOSTICS NA BAV014

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female