BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITY BIOLOGIX TAQPATH SARS-COV-2 ASSAY

    MDR report key: 11594678 · Received March 31, 2021

    Report

    Report Number
    3017938466-2021-00008
    Event Type
    Malfunction
    Date Received
    March 31, 2021
    Date of Event
    August 16, 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

    ORIGINAL TEST DATA REVIEWED AND WAS DETERMINED TO BE CONSISTENT WITH REPORTED RESULT. NO ADDITIONAL ANALYSIS OR INVESTIGATION NEEDED BASED ON DISTRIBUTOR ACTION. 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

    PATIENT INDICATES FALSE POSITIVE DUE TO NOT BEING EXPOSED TO ANYONE WHO HAS COVID AND THAT HIS SAMPLE ARRIVED TO THE LAB TOO FAST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    497778 INFINITY BIOLOGIX TAQPATH SARS-COV-2 ASSAY TAQPATH SARS-COV-2 ASSAY QJR INFINITY BIOLOGIX, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1