BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® FASTCLIX

    MDR report key: 24765932 · Received April 2, 2026

    Report

    Report Number
    3011393376-2026-00214
    Event Type
    Malfunction
    Date Received
    April 2, 2026
    Date of Event
    March 26, 2026
    Report Date
    May 12, 2026
    Manufacturer
    ROCHE DIABETES CARE, INC.
    Product Code
    QRL
    PMA / PMN Number
    K220608
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D4: CORRECTED THE CATALOG NUMBER ON THIS REPORT BASED ON THE RETURNED PRODUCT.

    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
    525773 ACCU-CHEK ® FASTCLIX LANCET DEVICE QRL ROCHE DIABETES CARE, INC. GDE052

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Unknown