BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELISWAB COVID-19 RAPID TEST

    MDR report key: 16145637 · Received January 12, 2023

    Report

    Report Number
    3004142665-2023-00005
    Event Type
    Malfunction
    Date Received
    January 12, 2023
    Date of Event
    January 4, 2023
    Report Date
    January 12, 2023
    Manufacturer
    ORASURE TECHNOLOGIES, INC
    Product Code
    QKP
    PMA / PMN Number
    EUA210378
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CONSUMER LEFT A REVIEW ON AMAZON.COM STATING THEY RECEIVED TWO FALSE NEGATIVE RESULTS FROM THE TESTS WITHIN THE SAME BOX. THE CONSUMER DID NOT PROVIDE A LOT NUMBER OR OTHER PRODUCT INFORMATION. PLEASE REFER TO MDR # 3004142665-2023-00006 FOR THE OTHER FALSE NEGATIVE SUBMISSION. 01/18/2023: ORASURE TECHNOLOGIES, INC REACHED OUT TO AMAZON IN AN ATTEMPT TO CONTACT THIS CONSUMER. ORASURE TECHNOLOGIES, INC IS UNABLE TO CONTACT CONSUMER PER AMAZON DIRECTIVES. NO FURTHER ACTION IS TO BE EXPECTED WITH THIS COMPLAINT AND THE INCIDENT WILL BE CLOSED INTERNALLY.

    Additional Manufacturer Narrative · 0

    CONSUMER LEFT A REVIEW ON AMAZON.COM STATING THEY RECEIVED TWO FALSE NEGATIVE RESULTS FROM THE TESTS WITHIN THE SAME BOX. THE CONSUMER DID NOT PROVIDE A LOT NUMBER OR OTHER PRODUCT INFORMATION. PLEASE REFER TO MDR # 3004142665-2023-00006 FOR THE OTHER FALSE NEGATIVE SUBMISSION.

    Description of Event or Problem · 0

    CONSUMER LEFT AN AMAZON REVIEW FOR INTELISWAB ON JANUARY 4TH, 2023 STATING THE FOLLOWING: "I BOUGHT THIS TEST AFTER READING THE VARIOUS REVIEWS WITH THOUGHTS THAT THIS WOULD BE AN ACCURATE TEST THAT TAKES LONGER FOR RESULTS. UPON RECEIVING THE TEST, I READ THE INSTRUCTIONS AND FOLLOWED THEM TO THE T AND GOT A NEGATIVE RESULT. I DECIDED THAT I WOULD TAKE THE OTHER TEST RIGHT AWAY AFTER BECAUSE THE SYMPTOMS WERE PRESENT FOR COVID AND GOT ANOTHER NEGATIVE RESULT. I THEN WENT TO GET A TEST DONE AT ONE OF THE COVID TEST LOCATIONS AND RECEIVED A POSITIVE RESULT. I AM NOT SURE I WOULD BUY THIS TEST AGAIN. THE CONCEPT IS THERE BUT THE ACCURACY IS FAULTY.'

    Description of Event or Problem · 0

    CONSUMER LEFT AN AMAZON REVIEW FOR INTELISWAB ON JANUARY 4TH, 2023 STATING THE FOLLOWING: "I BOUGHT THIS TEST AFTER READING THE VARIOUS REVIEWS WITH THOUGHTS THAT THIS WOULD BE AN ACCURATE TEST THAT TAKES LONGER FOR RESULTS. UPON RECEIVING THE TEST, I READ THE INSTRUCTIONS AND FOLLOWED THEM TO THE T AND GOT A NEGATIVE RESULT. I DECIDED THAT I WOULD TAKE THE OTHER TEST RIGHT AWAY AFTER BECAUSE THE SYMPTOMS WERE PRESENT FOR COVID AND GOT ANOTHER NEGATIVE RESULT. I THEN WENT TO GET A TEST DONE AT ONE OF THE COVID TEST LOCATIONS AND RECEIVED A POSITIVE RESULT. I AM NOT SURE I WOULD BUY THIS TEST AGAIN. THE CONCEPT IS THERE BUT THE ACCURACY IS FAULTY.'

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439001 INTELISWAB COVID-19 RAPID TEST INTELISWAB QKP ORASURE TECHNOLOGIES, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown