BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COVID-19 TEST KIT

    MDR report key: 10325819 · Received July 24, 2020

    Report

    Report Number
    MW5095708
    Event Type
    Malfunction
    Date Received
    July 24, 2020
    Date of Event
    July 20, 2020
    Report Date
    July 24, 2020
    Manufacturer
    LUMINEX ARIES
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    HI, US
    Reporter Occupation
    501

    Narratives

    Description of Event or Problem · 1

    A REPORTER CALLED TO REPORT A PATIENT'S COVID-19 TEST RESULT THAT CAME POSITIVE WITH LUMINEX AND WAS SENT TO DEPARTMENT OF HEALTH AND IT CAME BACK NEGATIVE. THE RESULT WAS QUESTIONED AND PATIENT RE-FLAGGED THEN THE LAB RUN THE TEST AGAIN WITH LUMINX AND THE RESULT WAS INVALID. THE TEST RESULT WITH PANTHER CAME BACK NEGATIVE. THE LIQUID AMIES MEDIA IS TAKEN OUT OF ROTATION FOR THIS PARTICULAR PATIENT. THE PATIENT TESTED ALTOGETHER 3 TIMES BUT SWABBED TWICE ON THE SAME DAY. WITH LUMINEX TEST KIT TWICE AND WITH PANTHER TEST KIT ONCE. PATIENT WAS ASYMPTOMATIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    783037 COVID-19 TEST KIT REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR LUMINEX ARIES
    783055 COVID-19 TEST KIT REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR LUMINEX ARIES
    783056 COVID-19 TEST KIT REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR HOLOGIC PANTHER

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR