BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFTCLIX ® LANCETS

    MDR report key: 23113970 · Received September 22, 2025

    Report

    Report Number
    3011393376-2025-00963
    Event Type
    Malfunction
    Date Received
    September 22, 2025
    Date of Event
    August 1, 2025
    Report Date
    December 19, 2025
    Manufacturer
    ROCHE DIABETES CARE, INC.
    Product Code
    QRK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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.

    Additional Manufacturer Narrative · 0

    CORRECTION TO FIELDS D1, D2A, D2B, D4, AND H5 BASED ON INVESTIGATION RESULTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE LANCET PROTRUDES FROM THE LANCET DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2069201 SOFTCLIX ® LANCETS LANCET QRK ROCHE DIABETES CARE, INC. 10523435

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male