BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMERDESIGN LTD COVID-19 GENESIG REAL-TIME PCR ASSAY

    MDR report key: 11177282 · Received January 14, 2021

    Report

    Report Number
    MW5098828
    Event Type
    Malfunction
    Date Received
    January 14, 2021
    Date of Event
    December 31, 2020
    Report Date
    January 12, 2021
    Manufacturer
    PRIMER DESIGN LIMITED
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    [COVID-19 RT PCR DIAGNOSIS] TREATMENT UNDER EMERGENCY USE AUTHORIZATION (EUA): PRIMERDESIGN LTD COVID-19 REAL-TIME PCR ASSAY. THIS IS ONE OF 8 DIFFERENT INDIVIDUALS FROM A SINGLE LOCATION IN MA TESTED FIRST BY BINAX NOW (+), THEN PCR NEGATIVE (-) BY THIS TEST WITH THE ORF1AB TARGET, FOLLOWED BY RT-PCR (+) AT TWO TARGETS (N1 AND N2) PERFORMED BY A DIFFERENT LABORATORY (MA STATE PUBLIC HEALTH LABORATORY). ORIGINAL THOUGHT WAS THAT THE BINAX NOW HAD EXHIBITED A FALSE POSITIVE- EXCEPT THE SECOND SWAB FROM ALL 8 INDIVIDUALS WERE POSITIVE BY A DIFFERENT COVID-19 PCR TEST. FIVE OF THE 8 SAMPLES WERE WHOLE GENOME SEQUENCED BY THE MA SPHL. QUALITATIVE TEST PRESENT OR ABSENT FOR ONE COVID-19 GENETIC TARGET. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    71070 PRIMERDESIGN LTD COVID-19 GENESIG REAL-TIME PCR ASSAY REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC QJR PRIMER DESIGN LIMITED

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other