BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABBOTT ID NOW COVID-19 ASSAY

    MDR report key: 12727851 · Received October 29, 2021

    Report

    Report Number
    MW5105028
    Event Type
    Injury
    Date Received
    October 29, 2021
    Date of Event
    October 24, 2021
    Report Date
    October 28, 2021
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QJR
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CT, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    [ABBOTT ID NOW COVID-19 ASSAY] USE FOR COVID-19 UNDER EMERGENCY USE. AUTHORIZATION (EUA): PATIENT ADMITTED FOR SEIZURE ACTIVITY. TESTED FOR COVID-19 USING THE ABBOTT ID NOW COVID-19 ASSAY ON (B)(6) 2021, RESULTED POSITIVE. NO COVID SYMPTOMS OTHER THAN WEAKNESS. PATIENT FULLY VACCINATED AGAINST COVID-19, + BOOSTER. PT LIVES ALONE WITH MINIMAL INTERACTION W/ OTHERS, AND NO IDENTIFIABLE CONTACT W/ COVID + PERSON. CONFIRMATORY CEPHEID PCR COVID TEST SENT TO LAB ON (B)(6) 2021 WAS NEGATIVE. ABBOTT ID NOW COVID-19 ASSAY WAS REPEATED ON (B)(6) 2021 AND WAS NEGATIVE. ON (B)(6) 2021 A REPEAT CEPHEID PCR WAS SENT AND WAS ALSO NEGATIVE. THIS IS BELIEVED TO BE A FALSE POSITIVE RESULT, WHICH WOULD OUR 3RD FALSE POSITIVE IN A PERIOD OF 3 WEEKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1616829 ABBOTT ID NOW COVID-19 ASSAY REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    1616830 ABBOTT ID NOW COVID-19 ASSAY REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    1616831 ABBOTT ID NOW COVID-19 ASSAY REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR