BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® MULTICLIX

    MDR report key: 3213385 · Received July 9, 2013

    Report

    Report Number
    1823260-2013-04144
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    June 13, 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
    NY, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND
    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

    CALLER REPORTED LANCET PROTRUDING FROM MULTICLIX LANCING DEVICE CAP. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE DEVICE AND LANCETS, REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312377 ACCU-CHEK ® MULTICLIX LANCET DEVICE FMK ROCHE DIAGNOSTICS NA WPZ030

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male