BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELISWAB COVID-19 RAPID TEST

    MDR report key: 24345524 · Received February 16, 2026

    Report

    Report Number
    3004142665-2026-00003
    Event Type
    Malfunction
    Date Received
    February 16, 2026
    Date of Event
    February 12, 2026
    Report Date
    February 16, 2026
    Manufacturer
    ORASURE TECHNOLOGIES, INC
    Product Code
    QKP
    PMA / PMN Number
    EUA210378
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE CONSUMER CALLED ORASURE TECHNOLOGIES, INC CONSUMER SUPPORT TO REPORT THEY RECEIVED 1 POSITIVE RESULT AND 3 NEGATIVE RESULTS USING INTELISWAB. THE CONSUMER ONLY HAD A LOT NUMBER FOR THE POSITIVE TEST RESULT AND DID NOT KNOW THE LOT NUMBER OF THE NEGATIVE TESTS. ADDITIONALLY, THE CONSUMER STATED THEY FOLLOWED INSTRUCTIONS BUT DID NOT OUTLINE SPECIFIC STEPS TAKEN. IT IS UNKNOWN IF A PCR TEST WAS USED TO CONFIRM THE PATIENT'S DIAGNOSIS. NO ADDITIONAL FOLLOW UP IS TO BE EXPECTED WITH THIS COMPLAINT AND THE INCIDENT WILL BE CLOSED INTERNALLY. CORRECTION TO INITIAL MDR SUBMISSION TO CORRECT MFR REPORT # AND B5 (DESCRIPTION).

    Additional Manufacturer Narrative · 0

    THE CONSUMER CALLED ORASURE TECHNOLOGIES, INC CONSUMER SUPPORT TO REPORT THEY RECEIVED 1 POSITIVE RESULT AND 3 NEGATIVE RESULTS USING INTELISWAB. THE CONSUMER ONLY HAD A LOT NUMBER FOR THE POSITIVE TEST RESULT AND DID NOT KNOW THE LOT NUMBER OF THE NEGATIVE TESTS. ADDITIONALLY, THE CONSUMER STATED THEY FOLLOWED INSTRUCTIONS BUT DID NOT OUTLINE SPECIFIC STEPS TAKEN. IT IS UNKNOWN IF A PCR TEST WAS USED TO CONFIRM THE PATIENTS DIAGNOSIS. NO ADDITIONAL FOLLOW UP IS TO BE EXPECTED WITH THIS COMPLAINT AND THE INCIDENT WILL BE CLOSED INTERNALLY.

    Description of Event or Problem · 0

    CONSUMER TOOK 1 TEST THAT WAS POSITIVE, AND THEN 3 MORE THAT WERE NEGATIVE. THE TESTS WERE ALL PERFORMED ON THE SAME DAY AND INSTRUCTIONS FOLLOWED ON ALL TESTS.THEY WOULD LIKE REPLACEMENT TEST. OPENED TEST AND SET UP VIAL IN STAND. BLEW NOSE AND THEN SWABBED NOSE AS INSTRUCTED. PUT IN VIAL AS INSTRUCTED. AT 30 MINUTES 2 FAINT LINES APPEARED. REFER TO MDR 3004142665-2026-00002 FOR THE POSITIVE RESULT. REFER TO THE BELOW MDRS FOR THE ADDITIONAL NEGATIVE RESULTS: 3004142665-2026-00004, 3004142665-2026-00005.

    Description of Event or Problem · 0

    CONSUMER TOOK 1 TEST THAT WAS POSITIVE, AND THEN 3 MORE THAT WERE NEGATIVE. THE TESTS WERE ALL PERFORMED ON THE SAME DAY AND INSTRUCTIONS FOLLOWED ON ALL TESTS.THEY WOULD LIKE REPLACEMENT TEST. OPENED TEST AND SET UP VIAL IN STAND. BLEW NOSE AND THEN SWABBED NOSE AS INSTRUCTED. PUT IN VIAL AS INSTRUCTED. AT 30 MINUTES 2 FAINT LINES APPEARED. REFER TO MDR 3004142665-2026-00002 FOR THE FALSE POSITIVE RESULT. REFER TO THE BELOW MDRS FOR THE ADDITIONAL 2 FALSE NEGATIVE RESULTS. 3004142665-2026-00004, 3004142665-2026-00005.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315671 INTELISWAB COVID-19 RAPID TEST INTELISWAB QKP ORASURE TECHNOLOGIES, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown