BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFTCLIX ® LANCET DEVICE

    MDR report key: 23873468 · Received December 22, 2025

    Report

    Report Number
    3011393376-2025-01199
    Event Type
    Malfunction
    Date Received
    December 22, 2025
    Date of Event
    December 13, 2025
    Report Date
    January 16, 2026
    Manufacturer
    ROCHE DIABETES CARE, INC.
    Product Code
    QRL
    UDI-DI
    04015630082209
    PMA / PMN Number
    K214022
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION - THE LANCET DEVICE LOT NUMBER, CATALOG NUMBER, UDI NUMBER, AND EXPIRATION DATE WERE UPDATED IN SECTION D BASED ON THE RETURNED PRODUCT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE LANCET DID NOT RETRACT FROM THE LANCET DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2318731 SOFTCLIX ® LANCET DEVICE LANCET DEVICE QRL ROCHE DIABETES CARE, INC. BBJ123 04015630082209

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male "GLUCOCIDE"| METFORMIN