BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA EXPERT

    MDR report key: 4932715 · Received July 22, 2015

    Report

    Report Number
    3011393376-2015-02014
    Event Type
    Malfunction
    Date Received
    July 22, 2015
    Date of Event
    June 29, 2015
    Report Date
    July 31, 2025
    Manufacturer
    ROCHE DIABETES CARE, INC.
    Product Code
    NBW
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
    Health Professional
    N

    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

    CALLER REPORTED THAT WHILE TRYING TO TURN ON THE METER IT WAS SMOKING AND SMELLED BURNT. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF THE ALLEGED DEVICE FOR EVALUATION; REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    474719 ACCU-CHEK ® AVIVA EXPERT BLOOD GLUCOSE MONITORING DEVICE NBW ROCHE DIABETES CARE, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Female