BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® MULTICLIX

    MDR report key: 3122785 · Received May 21, 2013

    Report

    Report Number
    1823260-2013-03087
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    April 4, 2013
    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
    IN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. 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

    UPON REVIEW BY THE MANUFACTURER'S INVESTIGATION UNIT, THE LANCET WAS FOUND TO PROTRUDE PAST THE END CAP OF THE DEVICE. NO ADVERSE EVENT REPORTED. SUSPECT DEVICE WAS RETURNED AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223832 ACCU-CHEK ® MULTICLIX LANCET DEVICE FMK ROCHE DIAGNOSTICS NA WPX126

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown