BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® SPIRIT

    MDR report key: 4782015 · Received May 19, 2015

    Report

    Report Number
    3011393376-2015-00471
    Event Type
    Malfunction
    Date Received
    May 19, 2015
    Date of Event
    April 26, 2015
    Report Date
    May 19, 2015
    Manufacturer
    ROCHE DIABETES CARE, INC.
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    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. (B)(6) DOESN'T ALLOW PRODUCT RETURN.

    Description of Event or Problem · 1

    SPIRIT INSULIN PUMP BUTTON WAS REPORTED NON-FUNCTIONAL. NO ADVERSE EVENT REPORTED. THE INFUSION DEVICE CANNOT BE RETURNED FOR LEGAL AND CUSTOMS ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    325592 ACCU-CHEK ® SPIRIT INSULIN INFUSION PUMP LZG ROCHE DIABETES CARE, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 017 YR