BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® FASTCLIX

    MDR report key: 23343166 · Received October 20, 2025

    Report

    Report Number
    3011393376-2025-01030
    Event Type
    Malfunction
    Date Received
    October 20, 2025
    Date of Event
    October 17, 2025
    Report Date
    November 20, 2025
    Manufacturer
    ROCHE DIABETES CARE, INC.
    Product Code
    QRL
    UDI-DI
    04015630065615
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    IN CHAPTER D, THE LOT NUMBER AND RELATED INFORMATION WAS UPDATED BASED ON THE RETURNED PRODUCT.

    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
    827377 ACCU-CHEK ® FASTCLIX LANCET DEVICE QRL ROCHE DIABETES CARE, INC. 33321014 04015630065615

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female