BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    METRIX COVID/FLU TEST

    MDR report key: 24916769 · Received April 17, 2026

    Report

    Report Number
    3017638293-2026-00009
    Event Type
    Malfunction
    Date Received
    April 17, 2026
    Report Date
    April 17, 2026
    Manufacturer
    APTITUDE MEDICAL SYSTEMS
    Product Code
    QLT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION INTO THIS COMPLAINT INCLUDED A CUSTOMER DATA REVIEW, A QUALITY DATA REVIEW AND A COMPLAINT HISTORY REVIEW. THERE WAS NO HARM TO THE PATIENT AS A RESULT OF THE FALSE NEGATIVE OUTSIDE OF SEEKING ADDITIONAL TESTING. THE IFU FOR THE METRIX COVID/FLU TEST INFORMS THE USER IN THE CASE OF A NEGATIVE RESULT: "A NEGATIVE RESULT INDICATES THAT SARS-COV-2 (THE VIRUS THAT CAUSES COVID-19), FLU A, AND FLU B WERE NOT DETECTED IN THE SAMPLE. HOWEVER, IT IS POSSIBLE FOR THIS TEST TO GIVE A NEGATIVE RESULT THAT IS NOT CORRECT (FALSE NEGATIVE) IN SOME PEOPLE WITH VIRAL INFECTION. NEGATIVE RESULTS DO NOT PRECLUDE SARS-COV-2/FLU A/FLU B INFECTION AND SHOULD NOT BE USED AS THE SOLE BASIS FOR TREATMENT OF AN INDIVIDUAL, INCLUDING INFECTION CONTROL DECISIONS. IF AN INDIVIDUAL HAS SYMPTOMS, CONTACT A HEALTHCARE PROVIDER FOR ADDITIONAL TESTING." THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR INVESTIGATION. THE ROOT CAUSE FOR A FALSE NEGATIVE 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 NEGATIVES WILL CONTINUE TO BE MONITORED.

    Description of Event or Problem · 0

    THE USER REPORTED A FALSE NEGATIVE RESULT WAS OBTAINED WITH THE METRIX COVID/FLU TEST BECAUSE A SUBSEQUENT CONTRADICTORY TEST RESULT WAS RECEIVED. CLINICAL FACTORS OR MEDICAL HISTORY OF THE SUBJECT AT THE TIME OF THE TEST WAS UNKNOWN. THE USER REPORTED THE CONTRADICTORY TEST RESULT CAME FROM A LAB PCR TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581444 METRIX COVID/FLU TEST COVID-19 MULTI-ANALYTE RESPIRATORY PANEL NUCLEIC ACID DEVICES QLT APTITUDE MEDICAL SYSTEMS REV C 20250904010

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown