BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® SPIRIT

    MDR report key: 4241356 · Received November 10, 2014

    Report

    Report Number
    1823260-2014-08753
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Date of Event
    July 28, 2014
    Report Date
    January 30, 2015
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    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.

    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. IT WAS ALSO REPORTED THAT THE RUBBER COVERING OF THE UP AND DOWN BUTTONS WAS DAMAGED. NO ADVERSE EVENT WAS REPORTED. THE INFUSION DEVICE WAS REQUESTED TO BE RETURNED FOR PRODUCT EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723733 ACCU-CHEK ® SPIRIT INSULIN INFUSION PUMP LZG ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 034 YR