BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® MULTICLIX

    MDR report key: 5212790 · Received November 9, 2015

    Report

    Report Number
    3011393376-2015-04928
    Event Type
    Malfunction
    Date Received
    November 9, 2015
    Date of Event
    October 21, 2015
    Report Date
    July 25, 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
    TX, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

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

    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 ADVERSE EVENT REPORTED. THE ALLEGED PRODUCT WAS REPLACED AND REQUESTED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    740389 ACCU-CHEK ® MULTICLIX LANCET DEVICE FMK ROCHE DIABETES CARE, INC. NA WPX170

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female