BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELISWAB COVID-19 RAPID TEST

    MDR report key: 20799603 · Received November 27, 2024

    Report

    Report Number
    3004142665-2024-00027
    Event Type
    Malfunction
    Date Received
    November 27, 2024
    Date of Event
    November 24, 2024
    Report Date
    November 27, 2024
    Manufacturer
    ORASURE TECHNOLOGIES, INC.
    Product Code
    QKP
    PMA / PMN Number
    EUA210378
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    OTI PERFORMED A REVIEW OF THE BATCH PRODUCTION RECORD. THE REVIEW DID NOT INDICATE ANY ABNORMALITIES THAT WOULD HAVE CONTRIBUTED TO THE FALSE POSITIVE RESULT. LOT 6705992 HAD A BATCH SIZE OF (B)(4) DEVICES, AND THERE WERE NO OTHER COMPLAINTS ASSOCIATED WITH THIS LOT. IT IS UNCLEAR HOW LONG THE CONSUMER WAS SYMPTOMATIC PRIOR TO TAKING THE FIRST INTELISWAB TEST. THE CONSUMER ALSO DID NOT PROVIDE THE NAME OF THE PCR TEST OR THE CT VALUES OF THE PCR TEST. SINCE OTI CANNOT DETERMINE THE ROOT CAUSE OF THE FALSE POSITIVE RESULT, THIS INVESTIGATION WILL BE CLOSED INTERNALLY AS UNCONFIRMED, AND NO ADDITIONAL FOLLOW UP IS TO BE EXPECTED. THE CONSUMER WILL RECEIVE A REPLACEMENT TEST KIT.

    Description of Event or Problem · 0

    THE CONSUMER CALLED ORASURE TECHNOLOGIES, INC. (OTI) ON (B)(6) 2024 TO REPORT THEY HAD RECEIVED A FALSE POSITIVE RESULT WHILE USING AN INTELISWAB TEST FROM LOT 6705992. THE CONSUMER STATED THEY TESTED ON SUNDAY, (B)(6) 2024 BECAUSE THEY WERE NOT FEELING WELL, AND RECEIVED A POSITIVE TEST RESULT. THE CONSUMER FOLLOWED UP WITH THEIR DOCTOR ON MONDAY, (B)(6) 2024 AND THE DOCTOR ADVISED THE CONSUMER TO GO TO URGENT CARE. THE URGENT CARE FACILITY TESTED THE CONSUMER USING ANOTHER RAPID TEST (BRAND UNKNOWN) AND RECEIVED A NEGATIVE TEST RESULT. THE URGENT CARE ALSO PERFORMED A PCR TEST, WHICH WAS NEGATIVE. THE CONSUMER ADVISED THEY PEFORMED ALL OF THE INSTRUCTIONS CORRECTLY AS INDICATED IN THE INSTRUCTIONS FOR USE. AFTER RECEIVING THE NEGATIVE TEST RESULTS FROM URGENT CARE, THE CONSUMER PERFORMED A FOLLOW UP TEST ON (B)(6) 2024 WITH THE SECOND INTELISWAB TEST IN THEIR KIT. THE CONSUMER RECEIVED A NEGATIVE RESULT WITH THE SECOND TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    843891 INTELISWAB COVID-19 RAPID TEST INTELISWAB QKP ORASURE TECHNOLOGIES, INC. 0006705992

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Unknown