BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    METRIX COVID-19 TEST

    MDR report key: 20196014 · Received September 11, 2024

    Report

    Report Number
    3017638293-2024-00004
    Event Type
    Malfunction
    Date Received
    September 11, 2024
    Date of Event
    August 8, 2024
    Report Date
    September 11, 2024
    Manufacturer
    APTITUDE MEDICAL SYSTEMS
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE USER CLAIMED THEY HAD A FALSE POSITIVE RESULT THAT WAS SUPPORTED BY SUBSEQUENTLY OBTAINING FOUR ADDITIONAL NEGATIVE TEST RESULTS OVER THE COURSE OF FOUR SUBSEQUENT DAYS. CLINICAL FACTORS OR MEDICAL HISTORY OF THE SUBJECT AT THE TIME OF TIME OF THE TEST WAS UNKNOWN. THERE WAS NO HARM TO THE USER AS A RESULT OF THE FALSE POSITIVE OUTSIDE OF SEEKING ADDITIONAL TESTING. THE IFU FOR THE METRIX COVID-19 TEST INFORMS THE USER IN THE CASE OF A FALSE POSITIVE RESULT: "POSITIVE RESULTS INDICATE THE PRESENCE OF VIRAL RNA, BUT CLINICAL CORRELATION WITH PAST MEDICAL HISTORY AND OTHER DIAGNOSTIC INFORMATION IS NECESSARY TO DETERMINE INFECTION STATUS. POSITIVE RESULTS DO NOT RULE OUT BACTERIAL INFECTION OR CO-INFECTION WITH OTHER VIRUSES. THE AGENT DETECTED MAY NOT BE THE DEFINITE CAUSE OF DISEASE. INDIVIDUALS WHO TEST POSITIVE WITH THE METRIX COVID-19 TEST SHOULD SELF-ISOLATE AND SEEK FOLLOW-UP CARE WITH THEIR PHYSICIAN OR HEALTHCARE PROVIDER AS ADDITIONAL TESTING MAY BE NECESSARY". THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR INVESTIGATION. THE ROOT CAUSE FOR A FALSE POSITIVE RESULT CANNOT BE DETERMINED AFTER THE DEVICE HAS BEEN USED TO RUN A TEST. AS PART OF THE INVESTIGATION, THE POTENTIAL ROOT CAUSES WERE REVIEWED TO ENSURE THEY WERE CAPTURED IN THE RISK ASSESSMENT AND THE RISK WAS FOUND TO BE ACCEPTABLE. REPORTS OF FALSE POSITIVES WILL CONTINUE TO BE MONITORED.

    Description of Event or Problem · 0

    THE USER REPORTED THAT ON (B)(6) 2024 THEY HAD A SUSPECTED FALSE POSITIVE. THE USER SUSPECTED THE FALSE POSITIVE BECAUSE THE USER SUBSEQUENTLY TOOK FOUR OTHER MOLECULAR TESTS OVER THE COURSE OF FOUR SUBSEQUENT DAYS WHICH ALL RESULTED IN A NEGATIVE RESULT. NO ADDITIONAL CLINICAL FACTORS OR MEDICAL HISTORY WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1474471 METRIX COVID-19 TEST COVID-19 NUCLEIC-ACID TEST QJR APTITUDE MEDICAL SYSTEMS REV-G 20240615012

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown