BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® FASTCLIX

    MDR report key: 4130228 · Received September 30, 2014

    Report

    Report Number
    1823260-2014-07452
    Event Type
    Malfunction
    Date Received
    September 30, 2014
    Date of Event
    September 8, 2014
    Report Date
    July 28, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FMK
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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 REPORTED. NO ADVERSE EVENT OCCURRED. CUSTOMER DID NOT PROVIDE THE LOT NUMBER OF THE LANCETS. THE MANUFACTURER REQUESTED RETURN OF SUSPECT PRODUCT FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608464 ACCU-CHEK ® FASTCLIX LANCET DEVICE FMK ROCHE DIAGNOSTICS NA GDZ212

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Male