BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® SPIRIT

    MDR report key: 4131275 · Received October 1, 2014

    Report

    Report Number
    1823260-2014-07456
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    September 5, 2014
    Report Date
    October 1, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    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) LAW DOESN'T ALLOW PRODUCT RETURN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BUTTON ON THE INFUSION DEVICE WAS NOT FUNCTIONING. AT THE TIME OF REPORT, IT WAS NOT SPECIFIED WHICH BUTTON. NO ADVERSE EVENT WAS REPORTED. THE INFUSION DEVICE CANNOT BE RETURNED FOR LEGAL AND CUSTOMS ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610381 ACCU-CHEK ® SPIRIT INSULIN INFUSION PUMP LZG ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 012 YR