BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® FASTCLIX

    MDR report key: 4892639 · Received July 6, 2015

    Report

    Report Number
    3011393376-2015-01599
    Event Type
    Malfunction
    Date Received
    July 6, 2015
    Date of Event
    June 25, 2015
    Report Date
    July 28, 2025
    Manufacturer
    ROCHE DIABETES CARE, INC.
    Product Code
    FMK
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6). THE YEAR IS THE ONLY KNOWN PART OF MANUFACTURE DATE. WE HAVE DEFAULTED TO THE FIRST OF THE YEAR. 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 · 1

    REPORTER STATED LANCET PROTRUDES BEYOND THE END CAP OF THE FASTCLIX DEVICE. NO ADVERSE EVENT REPORTED. THE ALLEGED PRODUCT WAS REQUESTED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437281 ACCU-CHEK ® FASTCLIX LANCET DEVICE FMK ROCHE DIABETES CARE, INC. NA GRZ024

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female