BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® MULTICLIX

    MDR report key: 4850731 · Received June 17, 2015

    Report

    Report Number
    3011393376-2015-01209
    Event Type
    Malfunction
    Date Received
    June 17, 2015
    Date of Event
    May 28, 2015
    Report Date
    July 28, 2025
    Manufacturer
    ROCHE DIABETES CARE, INC.
    Product Code
    FMK
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THE YEAR IS THE ONLY KNOWN PART OF MANUFACTURE DATE. WE HAVE DEFAULTED TO THE FIRST OF THE YEAR. IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    CUSTOMER REPORTED LANCET PROTRUDES BEYOND THE END CAP OF THE MULTICLIX DEVICE. NO ADVERSE EVENT REPORTED. THE ALLEGED PRODUCT WAS REPLACED AND REQUESTED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393032 ACCU-CHEK ® MULTICLIX LANCET DEVICE FMK ROCHE DIABETES CARE, INC. NA WPX159

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male