BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COVID-19 TEST KIT

    MDR report key: 10325783 · Received July 24, 2020

    Report

    Report Number
    MW5095707
    Event Type
    Malfunction
    Date Received
    July 24, 2020
    Date of Event
    June 18, 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 HOLOGIC PANTHER AND NEGATIVE WITH LUMINEX ARIES. THE PATIENT WAS TESTED AGAIN 2 TIMES WITH EACH MANUFACTURERS TEST KIT ALL THREE TIMES THEY GOT THE SAME RESULTS AS THE FIRST ONES. THE PATIENT WAS TESTED ALL TOGETHER 6 TIMES. THE LAB CONTACTED LUMINEX AND THEY WERE TOLD THE TEST IS NOT MEANT FOR SCREENING PURPOSES BECAUSE OF THE LIMITED DETECTION. THE REPORTER THINKS EITHER KITS MAY NOT NECESSARILY BE DEFECTIVE, BUT THE PANTHER ARIES MIGHT BE MORE SENSITIVE. THE PATIENT HAD AN ANTIBODY TEST AND THAT CAME POSITIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    783049 COVID-19 TEST KIT REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR LUMINEX ARIES
    783050 COVID-19 TEST KIT REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR LUMINEX ARIES
    783051 COVID-19 TEST KIT REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR LUMINEX ARIES
    783052 COVID-19 TEST KIT REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR HOLOGIC PANTHER
    783053 COVID-19 TEST KIT REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR HOLOGIC PANTHER
    783054 COVID-19 TEST KIT REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR HOLOGIC PANTHER

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR