BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® MULTICLIX

    MDR report key: 4800616 · Received May 27, 2015

    Report

    Report Number
    3011393376-2015-00673
    Event Type
    Malfunction
    Date Received
    May 27, 2015
    Date of Event
    May 20, 2015
    Report Date
    July 27, 2015
    Manufacturer
    ROCHE DIABETES CARE, INC.
    Product Code
    FPA
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6). WHILE THIS PRODUCT IS NOT SOLD IN THE UNITED STATES, IT IS LIKE OR SIMILAR TO A PRODUCT MARKETED IN THE UNITED STATES. THE YEAR IS THE ONLY KNOWN PART OF MANUFACTURE DATE. WE HAVE DEFAULTED TO THE FIRST OF THE YEAR.

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6). WHILE THIS PRODUCT IS NOT SOLD IN THE UNITED STATES, IT IS LIKE OR SIMILAR TO A PRODUCT MARKETED IN THE UNITED STATES.

    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 REQUESTED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343626 ACCU-CHEK ® MULTICLIX LANCET DEVICE FPA ROCHE DIABETES CARE, INC. NA WPZ058

    Patients

    Seq Age Sex Outcome Treatment
    1