BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 4223122 · Received November 4, 2014

    Report

    Report Number
    1823260-2014-08502
    Event Type
    Malfunction
    Date Received
    November 4, 2014
    Date of Event
    October 6, 2014
    Report Date
    July 28, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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

    CUSTOMER REPORTED HAVING LOW BLOOD GLUCOSE SYMPTOMS WITH RESULTS OF 7.9 MMOL/L AND 8.2 MMOL/L OBTAINED ON THE AVIVA STRIPS. THE CUSTOMER'S HUSBAND WAS ABLE TO TREAT HER WITH A CHOCOLATE BAR AND LOW BLOOD GLUCOSE SYMPTOMS IMPROVED WITHIN 10-15 MINUTES. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT RELATED TO THE DEVICE WAS REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    706250 ACCU-CHEK ® AVIVA TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 493675

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female METFORMIN| UNK LONG-ACTING INSULIN| VICTOZA| UNK LONG-ACTING INSULIN| METFORMIN| VICTOZA