BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFTCLIX ® LANCET DEVICE

    MDR report key: 25049811 · Received April 30, 2026

    Report

    Report Number
    3011393376-2026-00257
    Event Type
    Malfunction
    Date Received
    April 30, 2026
    Date of Event
    April 13, 2026
    Report Date
    May 26, 2026
    Manufacturer
    ROCHE DIABETES CARE, INC.
    Product Code
    QRL
    PMA / PMN Number
    K214022
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT OCCURRED OUTSIDE OF THE UNITED STATES. 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 · 0

    IT WAS REPORTED THAT THE LANCET PROTRUDES BEYOND THE END CAP OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124759 SOFTCLIX ® LANCET DEVICE LANCET DEVICE QRL ROCHE DIABETES CARE, INC. ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown