BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA PLUS

    MDR report key: 23093289 · Received September 19, 2025

    Report

    Report Number
    3011393376-2025-00956
    Event Type
    Malfunction
    Date Received
    September 19, 2025
    Date of Event
    September 10, 2025
    Report Date
    November 26, 2025
    Manufacturer
    ROCHE DIABETES CARE, INC.
    Product Code
    LFR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    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 · 0

    IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 50 - 100 MG/DL WITH THE ACCU-CHEK AVIVA SYSTEM AND 170 - 187 MG/DL WITH A PROFESSIONAL METER. THE CUSTOMER COULD NOT PROVIDE MORE PRECISE RESULTS THAN THE MENTIONED RANGE. HE STATED THIS SAME ISSUE HAPPENED ON (B)(6) 2025, AROUND 7:00PM AS WELL AS ON (B)(6) 2025, AROUND 8:00PM. THE SAME ACCU-CHEK AVIVA TEST STRIPS LOT WAS USED FOR THE MEASUREMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288260 ACCU-CHEK ® AVIVA PLUS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIABETES CARE, INC. 690750

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Male