BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    METRIX COVID-19 TEST

    MDR report key: 20081592 · Received August 27, 2024

    Report

    Report Number
    3017638293-2024-00001
    Event Type
    Malfunction
    Date Received
    August 27, 2024
    Date of Event
    July 26, 2024
    Report Date
    August 27, 2024
    Manufacturer
    APTITUDE MEDICAL SYSTEMS
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTER CLAIMED THAT THE DEVICE PRODUCED A FALSE POSITIVE RESULT WHICH WAS CONFIRMED BY ADDITIONAL TESTS TAKEN, SUCH AS A LUCIRA AND A PCR TEST, WHICH HAD RESULTED IN NEGATIVE RESULTS. THERE WAS NO HARM TO THE PATIENT 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. THIS IS THE FIRST REPORT OF A FALSE POSITIVE RESULT. REPORTS OF FALSE POSITIVES WILL CONTINUE TO BE MONITORED, AND THERE ARE NO OTHER RECOMMENDED ACTIONS AT THIS POINT.

    Description of Event or Problem · 0

    THE MOTHER OF THE USER REPORTED THAT ON (B)(6) 2024, HER SON HAD TAKEN A TEST WHICH YIELDED A POSITIVE TEST RESULT. HOWEVER, THE SON TOOK A MULTIPLE ANTIGEN AND A LUCIRA WHICH WERE ALL NEGATIVE. WHEN THEY TOOK THE METRIX TEST AGAIN, IT AGAIN SHOWED A POSITIVE RESULT. THE SON ALSO HAD A LAB PCR COMPLETED AT A HOSPITAL WHICH RESULTED NEGATIVE. ON (B)(6) 2024, THE MOTHER THEN TESTED HER SON AGAIN, ONCE MORE WITH THE LUCIRA AND AGAIN WITH THE METRIX. BOTH THEN YIELDED NEGATIVE RESULTS. THE MOTHER CLAIMS SHE STRONGLY BELIEVES THE RESULTS WERE FALSE POSITIVES. APTITUDE MEDICAL WAS MADE AWARE OF THIS EVENT ON 07/28/2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    158359 METRIX COVID-19 TEST COVID-19 NUCLEIC-ACID TEST QJR APTITUDE MEDICAL SYSTEMS REV G 20240614011

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male