BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITY BIOLOGIX TAQPATH SARS-COV-2 ASSAY

    MDR report key: 11613020 · Received April 5, 2021

    Report

    Report Number
    3017938466-2021-00053
    Event Type
    Malfunction
    Date Received
    April 5, 2021
    Date of Event
    November 28, 2020
    Report Date
    March 31, 2021
    Manufacturer
    INFINITY BIOLOGIX, LLC
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETEST OF THE ORIGINAL SAMPLE RESULTED IN A NEGATIVE TEST RESULT. IT'S A POTENTIAL FALSE POSITIVE RESULT. RECENT LITERATURE HAS DEMONSTRATED THAT SALIVA BASED TESTING METHODS ARE MORE ACCURATE AND MORE SENSITIVE THAN THE NASAL SWAB. REFERENCE: OMER SB, SIMONOV M, WARREN JL, ET AL. SALIVA OR NASOPHARYNGEAL SWAB SPECIMENS FOR DETECTION OF SARS-COV-2. THE NEW ENGLAND JOURNAL OF MEDICINE. 2020;383(13):1283-1286. DOI:10.1056/NEJMC2016359.

    Description of Event or Problem · 1

    FALSE RESULT BASED ON TESTING DAY WHERE MORE THAN ONE PERSON SUBSEQUENTLY TESTED NEGATIVE THIS IS HISTORIC COMPLAINT. SUBMISSION INITIALLY SUBMITTED VIA E-MAIL IN ABSENCE OF EMDR REPORTING NOT SETUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    514330 INFINITY BIOLOGIX TAQPATH SARS-COV-2 ASSAY TAQPATH SARS-COV-2 ASSAY QJR INFINITY BIOLOGIX, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1