BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTI SARS-COV-2 RT PCR TEST

    MDR report key: 11893894 · Received May 27, 2021

    Report

    Report Number
    3004102403-2021-00001
    Event Type
    Malfunction
    Date Received
    May 27, 2021
    Date of Event
    May 7, 2021
    Report Date
    May 12, 2021
    Manufacturer
    OPTI MEDICAL SYSTEMS, INC.
    Product Code
    QJR
    PMA / PMN Number
    EUA200215
    Removal / Correction Number
    Z-2310-2021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 0

    CLIA LAB IN PORTLAND MAINE REPORTED THEY WERE SEEING FALSE POSITIVE RESULTS ON SOME OF OUR TESTS. OUR INVESTIGATION INTERNALLY HAS SHOWN THAT OUR RNA MASTER MIX CAN HAVE PRECIPITATE THAT CAN CAUSE THIS ISSUE. THE PRECIPITATE CAN CAUSE FALSE POSITIVE RESULTS WITH A RATE OF 5-10 % IN AROUND 20 % OF THE AFFECTED KIT LOT NUMBERS.

    Description of Event or Problem · 1

    (B)(6) REPORTED THEY WERE SEEING FALSE POSITIVE RESULTS ON SOME OF OUR TESTS. OUR INVESTIGATION INTERNALLY HAS SHOWN THAT OUR RNA MASTER MIX CAN HAVE PRECIPITATE THAT CAN CAUSE THIS ISSUE. THE PRECIPITATE CAN CAUSE FALSE POSITIVE RESULTS WITH A RATE OF ~ 5 - 10 % IN AROUND 20 % OF THE AFFECTED KIT LOT NUMBERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    795388 OPTI SARS-COV-2 RT PCR TEST OPTI SARS-COV-2 RT PCR TEST QJR OPTI MEDICAL SYSTEMS, INC. OPTI SARS-COV-2 RT-PCR 20712

    Patients

    Seq Age Sex Outcome Treatment
    1