BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCULA SARS COV-2 TEST

    MDR report key: 11905701 · Received May 29, 2021

    Report

    Report Number
    3013022608-2021-00010
    Event Type
    Malfunction
    Date Received
    May 29, 2021
    Date of Event
    January 11, 2021
    Report Date
    May 29, 2021
    Manufacturer
    MESA BIOTECH
    Product Code
    QJR
    PMA / PMN Number
    EUA200028
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    505

    Narratives

    Additional Manufacturer Narrative · 1

    CAPA IMPLEMENTED TO ENSURE HEATER ALIGNMENT. RISK ASSESSMENT - RISK DEEMED ACCEPTABLE. ORIGINAL SUBMISSION FAILED ACKNOWLEDGEMENT 3 (ACK3) AND WAS NOT REALIZED UNTIL MAY 2021. MESA WORKED WITH THE ESG HELP DESK. THEIR RESPONSE AS FOLLOWS: THANK YOU FOR PROVIDING THE ACK3 FILE AND INVESTIGATING THE ISSUE WITH THE REPORTS. PLEASE NOTE, YOUR FIRM'S FEI NUMBER IS THE FIRST PART OF THE "MFR REPORT NUMBER" . WE CHECKED THE FDA ESTABLISHMENT REGISTRATION & DEVICE LISTING DATABASE AND IT SHOWS MESA BIOTECH INC. FEI NUMBER AS (B)(4). PLEASE RE-OPEN YOUR SUBMISSIONS IN ESUBMITTER, CORRECT THE REPORT NUMBERS USING YOUR FIRM'S REAL FEI NUMBER TO CORRECT THE ISSUE AND RESUBMIT THE FILES IN WEBTRADER.

    Description of Event or Problem · 1

    CUSTOMER CALLED IN ABOUT MELTING CASSETTES. NO ADVERSE EVENT OCCURRED. RISK ASSESSMENT PERFORMED. THE USED DEVICES WERE NOT RETURNED TO THE MANUFACTURER, BUT DEVICES MANUFACTURE AND QC RESULTS FROM THE SAME LOT WERE EVALUATED WITH NO ISSUES. THE MANUFACTURER HAS CONFIRMED THAT THE DEVICE MALFUNCTIONED. INFORMATION REPORTED BY USER IS BEING REPORTED AS REQUIRED BY 21 CFR 803.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    802148 ACCULA SARS COV-2 TEST MOLECULAR SINGLE TARGET TEST FOR SARS COV-2 QJR MESA BIOTECH REF4100 20102706

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR