BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA EXPERT

    MDR report key: 10493194 · Received September 4, 2020

    Report

    Report Number
    3011393376-2020-03204
    Event Type
    Malfunction
    Date Received
    September 4, 2020
    Date of Event
    August 31, 2020
    Report Date
    July 23, 2025
    Manufacturer
    ROCHE DIABETES CARE, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED OUTSIDE OF 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

    IT WAS REPORTED THAT THE BOLUS RECOMMENDATIONS PROVIDED BY THE BLOOD GLUCOSE MONITOR ARE NOT ACCURATE. THE FOLLOWING EVENTS CAUSED CONCERN FOR THE CUSTOMER'S MOTHER: (B)(6) 2020, AT 12:00 NOON 7,4 MMOL/L, CARBOHYDRATE 48 GRAM, NO HEALTH EVENTS, ADVICE 8 INSULIN UNITS. (B)(6) 2020, AT 12:00 NOON, 5,2 MMOL/L, CARBOHYDRATE 60 GRAM, NO HEALTH EVENTS, ADVICE 10 INSULIN UNITS. THE AVIVA EXPERT BOLUS SIMULATOR SHOWS THAT THE BOLUS ADVISE SHOULD HAVE BEEN 2.5 UNITS, ON (B)(6) 2020 AT 12:00 NOON, WHEN THE BLOOD GLUCOSE VALUE WAS 7.4 MMOL/L AND THE CARBOHYDRATE 48 GRAM. INSTEAD THE AVIVA EXPERT METER ADVISED 8 UNITS. THE INCORRECT BOLUS' OF 8U AND 10U WERE NOT ADMINISTERED TO THE CUSTOMER, NO ADVERSE EVENT OCCURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    957841 ACCU-CHEK ® AVIVA EXPERT BLOOD GLUCOSE MONITORING DEVICE NBW ROCHE DIABETES CARE, INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Female UNKNOWN INSULIN