BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    METRIX COVID TEST

    MDR report key: 24070713 · Received January 14, 2026

    Report

    Report Number
    MW5182246
    Event Type
    Malfunction
    Date Received
    January 14, 2026
    Date of Event
    January 10, 2026
    Report Date
    January 12, 2026
    Manufacturer
    APTITUDE MEDICAL SYSTEMS
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    117
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    MILD SORE THROAT, POSITIVE METRIX COVID TEST, SUSPECTED FALSE POSITIVE. PATIENT HAD BEEN HOUSEBOUND FOR >2 WEEKS DUE TO INJURY. PATIENT'S HOUSEHOLD OF SIX CONSISTENTLY WEAR RESPIRATORS IN PUBLIC, NO KNOWN EXPOSURES, ALL ASYMPTOMATIC, ALL TESTED NEGATIVE WITH METRIX SAME DAY. PATIENT ISOLATED, TESTED NEGATIVE LATER THAT DAY WITH BINAX, CONTINUED TO ISOLATE, TESTED NEGATIVE DAILY X 2 WITH METRIX. SYMPTOMS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138175 METRIX COVID TEST REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR APTITUDE MEDICAL SYSTEMS 20240723007

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Female