BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® MULTICLIX

    MDR report key: 4230076 · Received November 6, 2014

    Report

    Report Number
    1823260-2014-08606
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    October 10, 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
    CA, 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.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715370 ACCU-CHEK ® MULTICLIX LANCET DEVICE FMK ROCHE DIAGNOSTICS NA WIR027

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown