BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAQPATH COVID 19 DIAGNOSTIC TEST EUA200010/A001

    MDR report key: 10319544 · Received July 23, 2020

    Report

    Report Number
    MW5095681
    Event Type
    Injury
    Date Received
    July 23, 2020
    Date of Event
    July 16, 2020
    Report Date
    July 22, 2020
    Manufacturer
    THERMO FISHER / LIFE TECHNOLOGIES CORPORATION
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    FALSE POSITIVE TEST REPORT: THERMO FISHER SCIENTIFIC EUA200010/A001 COVID-19 PERFORMED IN (B)(6) FOR INTERNATIONAL TRAVEL CLEARANCE. THE TEST LAB IS (B)(6). NO SYMPTOMS AND NO EXPOSURE BUT A POSITIVE RESULT. ANOTHER TEST WAS IMMEDIATELY DONE ON BOTH MYSELF AND MY WIFE AND BOTH TEST WERE NEGATIVE. THE BOARD OF HEALTH IN (B)(6) DID THEIR OWN TEST AND CONFIRMED THAT IT WAS NEGATIVE AND I HAD NO COVID INFECTION. HAVE TRIED NUMEROUS TIMES TO CONTACT (B)(6), BUT HAVE NOT HAD A REPLY. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    782186 TAQPATH COVID 19 DIAGNOSTIC TEST EUA200010/A001 REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR THERMO FISHER / LIFE TECHNOLOGIES CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other| R