BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    METRIX COVID-19 TEST READER

    MDR report key: 19974899 · Received August 12, 2024

    Report

    Report Number
    MW5158353
    Event Type
    Malfunction
    Date Received
    August 12, 2024
    Date of Event
    August 7, 2024
    Report Date
    August 7, 2024
    Manufacturer
    APTITUDE MEDICAL SYSTEMS
    Product Code
    QLW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    LIKELY FALSE POSITIVE FROM APTITUDE MEDICAL SYSTEMS' METRIX COVID-19 TEST. I COMPLETED A TEST AND IT RETURNED A POSITIVE RESULT FOR COVID-19. I WENT TO RE-TEST, AND THE NEXT TEST I INSERTED INTO THE METRIX READER INDICATED A "READ ERROR" (TWO FLASHING RED LAMPS). ASSUMING A FAULT WITH THE TEST ITSELF, I PREPARED A THIRD TEST, WHICH ALSO INDICATED A READ ERROR. AFTER BLOWING OUT THE SLOT IN THE METRIX READER WHERE TESTS ARE INSERTED, I REINSERTED THE THIRD TEST, WHICH COMPLETED AND RETURNED NEGATIVE. ALL TESTS ARE OF LOT 20240420010. ON THE BASIS THAT THE FIRST TEST MAY HAVE INTRODUCED FOREIGN MATERIAL INTO THE METRIX READER THAT SOMEHOW RESULTED IN A POSITIVE RESULT FOR THAT TEST, AND READ ERRORS WHEN STARTING SUBSEQUENT TESTS, I WENT TO AN URGENT CARE CLINIC TO HAVE A COVID-19 PCR TEST DONE, WHICH RETURNED NEGATIVE. POINT-OF-CARE (20 MINUTE) TEST AT URGENT CARE CLINIC, UNKNOWN MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1894706 METRIX COVID-19 TEST READER COVID-19 TEST HOME COLLECTION KIT DEVICES QLW APTITUDE MEDICAL SYSTEMS 810-00012 20240420010

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Prefer Not To Disclose ADDERALL XR| ESTRADIOL VALERATE| LACTASE SUPPLEMENT| METRIX COVID-19 TEST