BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RT-PCR TEST ACCULA SARS-COV-2 TEST

    MDR report key: 12301252 · Received August 9, 2021

    Report

    Report Number
    MW5103103
    Event Type
    Malfunction
    Date Received
    August 9, 2021
    Date of Event
    August 2, 2021
    Report Date
    August 5, 2021
    Manufacturer
    MESA BIOTECH, INC.
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    WENT TO COVID CLINIC, IN (B)(6) FOR THREE RT-PCR TESTS (AT (B)(6) EACH). WHEN WE HADN'T RECEIVED TWO OF THE RESULTS SIX HOURS LATER (WE WERE TOLD 30 MINUTES) I RETURNED IN PERSON. THEY SENT THE TWO REMAINING TESTS, BUT I DID NOT RECEIVE THE EMAIL. SO, THEY RE-SENT ALL THREE TESTS, WHICH I RECEIVED ALMOST IMMEDIATELY AND LEFT. TODAY, I AM PREPARING TO SEND THE PAPERWORK TO MY INSURANCE COMPANY, WHEN I NOTICE THAT THE TWO COPIES FOR ONE PATIENT HAVE CONFLICTING RESULTS. IN OTHER WORDS, FOR ONE PATIENT AND ONE SAMPLE SERIAL NUMBER, WE RECEIVED A POSITIVE AND A NEGATIVE RESULT. CLEARLY THE PRACTICES AND PROCEDURES AT THIS SITE ARE NOT SUFFICIENT TO PREVENT SERIOUS ERRORS. ADDITIONALLY, ALL THREE SWABS WERE TAKEN AT APPROXIMATELY 10:00AM (WE ARRIVED IN THE SAME CAR). THE TEST RECORDS INDICATE COLLECTION AT 12:16, 15:56, AND 15:57. IT APPEARS THEY ARE FUDGING THE RECORDS, IN ORDER TO SHOW A 1 HOUR TEST TIME (AS ADVERTISED). FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1191367 RT-PCR TEST ACCULA SARS-COV-2 TEST REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR MESA BIOTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR