BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCULA

    MDR report key: 12474516 · Received September 14, 2021

    Report

    Report Number
    MW5103915
    Event Type
    Malfunction
    Date Received
    September 14, 2021
    Date of Event
    September 7, 2021
    Report Date
    September 10, 2021
    Manufacturer
    MESA BIOTECH, INC / THERMO FISHER SCIENTIFIC
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I RECEIVED A POSITIVE ACCULA RAPID PCR TEST, 2 DAYS AFTER I BEGAN HAVING SYMPTOMS OF ALLERGIES, I SUBSEQUENTLY RECEIVED 3 NEGATIVE TESTS FOLLOWING THE FIRST POSITIVE, 2 NEGATIVE ANTIGEN TESTS AND 1 ADDITIONAL NEGATIVE PCR ON (B)(6) 2021. THE MEDICAL OFFICE THAT GAVE ME THE POSITIVE RESULT ALSO FALSIFIED MY MEDICAL RECORDS ADDING INTO THE NOTES THAT I HAD RECENTLY LOST OF TASTE AND SMELL TO COINCIDE WITH THE POSITIVE RESULT. I NEVER HAD THOSE SYMPTOMS. THIS OCCURRED AT A (B)(6) URGENT CARE IN (B)(6). THEY CLAIM THEY ARE INVESTIGATING IT. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1368933 ACCULA REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR MESA BIOTECH, INC / THERMO FISHER SCIENTIFIC

    Patients

    Seq Age Sex Outcome Treatment
    1