BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK AVIVA TEST STRIPS

    MDR report key: 10190959 · Received June 24, 2020

    Report

    Report Number
    3011393376-2020-02224
    Event Type
    Malfunction
    Date Received
    June 24, 2020
    Date of Event
    June 22, 2020
    Report Date
    September 11, 2020
    Manufacturer
    ROCHE DIABETES CARE, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    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 THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES ON (B)(6) 2020: 437 MG/DL, 218 MG/DL AND 184 MG/DL. IT WAS REPORTED THE PATIENT ALSO RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES ON (B)(6) 2020: 440 MG/DL AND 112 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652704 ACCU-CHEK AVIVA TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS NBW ROCHE DIABETES CARE, INC. 498585

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR