BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® FASTCLIX

    MDR report key: 3941575 · Received July 17, 2014

    Report

    Report Number
    1823260-2014-05306
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    June 3, 2014
    Report Date
    July 29, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FMK
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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.

    Description of Event or Problem · 1

    REPORTER STATED LANCET PROTRUDES BEYOND THE END CAP OF THE FASTCLIX DEVICE. NO ACCIDENTAL STICK OCCURRED. NO ADVERSE EVENT REPORTED. THE MANUFACTURER REQUESTED RETURN OF SUSPECT PRODUCT FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419505 ACCU-CHEK ® FASTCLIX LANCET DEVICE FMK ROCHE DIAGNOSTICS NA GWY003

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male