BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCULA SARS-COV-2 TEST

    MDR report key: 11453043 · Received March 9, 2021

    Report

    Report Number
    MW5099869
    Event Type
    Malfunction
    Date Received
    March 9, 2021
    Date of Event
    March 9, 2021
    Report Date
    March 9, 2021
    Manufacturer
    MESA BIOTECH, INC.
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    REPORTER STATES A PEDIATRIC PATIENT WAS SCHEDULED FOR A DOCTORS APPOINTMENT AND HAD PRESENTED WITH LOW GRADE FEVER. WITH CONCERNS FOR COVID-19, DOCTOR ORDERED RAPID COVID-19 TEST FOR PATIENT PRIOR TO ENTRY TO THE BUILDING. PATIENT SAMPLE WAS ACQUIRED AT A POINT OF CARE RAPID COVID TEST SITE AND RUN USING THE ACCULA SARS-COV-2 TEST. REPORTER STATES THAT THE PATIENT SAMPLE WAS RUN IN THE FIRST CASSETTE AND ABOUT 10 MINUTES INTO THE TEST, THE MACHINE FLASHED ERROR CODE 15 AND NO RESULT WAS OBTAINED. THE REPORTER STATES THAT PATIENT SAMPLE WAS THEN TESTED USING A DIFFERENT TEST CASSETTE AND DOCK WHERE SHE NOTES THE SAMPLE RAN THE FULL 30 MINUTES WITHOUT A RESULT OBTAINED. REPORTER NOTES THAT THERE WAS A BLUE LINE GOING DOWN AND THAT ALL TESTING LANES WERE EMPTY. REPORTER STATES THAT ON THE 3RD ATTEMPT DURING A DIFFERENT CASSETTE AND DOCK A NEGATIVE TEST RESULT WAS OBTAINED. OF NOTE, REPORTER STATES THAT PRIOR TO THE REPORTED MALFUNCTION, ALL CONTROLS THAT WERE RUN IN THE MORNING HAD NO ISSUE. REPORTER STATES THAT NO MEDICAL INTERVENTION WAS NEEDED AS A RESULT OF DELAYED TEST AND THAT THE PATIENT WAS SEEN BY DOCTOR LATER IN THE DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    345900 ACCULA SARS-COV-2 TEST REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR MESA BIOTECH, INC. V2102E036K
    345901 ACCULA SARS-COV-2 TEST REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR MESA BIOTECH, INC V2102E036K

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR