BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFTCLIX ® LANCET DEVICE

    MDR report key: 23582755 · Received November 18, 2025

    Report

    Report Number
    3011393376-2025-01099
    Event Type
    Malfunction
    Date Received
    November 18, 2025
    Date of Event
    November 11, 2025
    Report Date
    December 2, 2025
    Manufacturer
    ROCHE DIABETES CARE, INC.
    Product Code
    QRL
    UDI-DI
    04015630082209
    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
    1494668 SOFTCLIX ® LANCET DEVICE LANCET DEVICE QRL ROCHE DIABETES CARE, INC. BBI266 04015630082209

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female