BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCULA FLU A / FLU B TEST

    MDR report key: 16369032 · Received February 13, 2023

    Report

    Report Number
    3013022608-2023-00374
    Event Type
    Malfunction
    Date Received
    February 13, 2023
    Date of Event
    January 16, 2023
    Report Date
    February 3, 2023
    Manufacturer
    MESA BIOTECH
    Product Code
    OZE
    PMA / PMN Number
    K171641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MESA CONTINUES TO TRACK, TREND, CAPA ASSIGNED, AND REACT TO CUSTOMER COMPLAINTS. NO ADVERSE EVENT OCCURRED. THE MANUFACTURER HAS NOT CONFIRMED THAT THE DEVICE MALFUNCTIONED. INFORMATION REPORTED BY USER IS BEING REPORTED AS REQUIRED BY 21 CFR 803.

    Description of Event or Problem · 0

    CUSTOMER REPORTED FALSE NEGATIVE. INFORMATION REPORTED BY USER IS BEING REPORTED AS REQUIRED BY 21 CFR 866.3980.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2251204 ACCULA FLU A / FLU B TEST RESPIRATORY VIRAL PANEL MULTIPLEX NUCLEIC ACID ASSAY OZE MESA BIOTECH FAB1100CW P22314-022

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR Unknown