BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® SPIRIT COMBO

    MDR report key: 6090782 · Received November 9, 2016

    Report

    Report Number
    3011393376-2016-07238
    Event Type
    Malfunction
    Date Received
    November 9, 2016
    Date of Event
    October 25, 2016
    Report Date
    December 5, 2016
    Manufacturer
    ROCHE DIABETES CARE, INC.
    Product Code
    LZG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED OUTSIDE THE UNITED STATES. 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

    THE PATIENT REPORTS THAT WHEN HE DOES A BOLUS, THE INSULIN PUMP DOESN'T VIBRATE ANYMORE. NO ADVERSE EVENT ALLEGED. A REQUEST WAS MADE FOR THE RETURN OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    739562 ACCU-CHEK ® SPIRIT COMBO INSULIN INFUSION PUMP LZG ROCHE DIABETES CARE, INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1