BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA EXPERT

    MDR report key: 4781472 · Received May 19, 2015

    Report

    Report Number
    3011393376-2015-00441
    Event Type
    Malfunction
    Date Received
    May 19, 2015
    Date of Event
    April 22, 2015
    Report Date
    August 12, 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
    PATIENT
    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

    IT WAS REPORTED THAT THE PATIENT ALLEGES THE BOLUS RECOMMENDATIONS PROVIDED BY THE BLOOD GLUCOSE MONITOR ARE NOT ACCURATE. NO ADVERSE EVENT WAS REPORTED. THE BLOOD GLUCOSE MONITOR WAS REQUESTED TO BE RETURNED FOR PRODUCT EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    326837 ACCU-CHEK ® AVIVA EXPERT BLOOD GLUCOSE MONITORING DEVICE NBW ROCHE DIABETES CARE, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Male