BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELISWAB COVID-19 RAPID TEST

    MDR report key: 15500925 · Received September 28, 2022

    Report

    Report Number
    3004142665-2022-00032
    Event Type
    Malfunction
    Date Received
    September 28, 2022
    Date of Event
    September 19, 2022
    Report Date
    October 13, 2022
    Manufacturer
    ORASURE TECHNOLOGIES, INC.
    Product Code
    QKP
    PMA / PMN Number
    EUA210378
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    9/29/2022- THE CONSUMER LEFT A COMMENT ON AN INTELISWAB FACEBOOK POST, STATING THAT THE TEST RESULTS THEY RECEIVED WERE WRONG. DUE TO THE LACK OF INFORMATION PROVIDED BY THE CONSUMER, IT IS UNCLEAR WHETHER THE CONSUMER RECEIVED A FALSE NEGATIVE OR FALSE POSITIVE RESULT. THEREFORE, ORASURE TECHNOLOGIES, INC. HAS CHOSEN TO REPORT THE CONSUMERS COMPLAINT, AS BOTH A FALSE NEGATIVE AND FALSE POSITIVE RESULT. REFER TO MDR 3004142665-2022-00033 FOR THE FALSE POSITIVE SUBMISSION. 9/30/2022- REVISED SECTION G6 TO REFLECT FOLLOWUP. 10/13/2022- THE CONSUMER LEFT A COMMENT ON AN INTELISWAB FACEBOOK POST STATING THEY RECEIVED FALSE RESULTS. MDR 3004142665-2022-00033 WAS SUBMITTED IN ERROR, AND IS A DUPLICATE SUBMISSION. THE FALSE RESULT REPORTED BY THE CONSUMER IS ONLY CAPTURED IN THIS MDR.

    Additional Manufacturer Narrative · 0

    (B)(6)2022- THE CONSUMER LEFT A COMMENT ON AN INTELISWAB FACEBOOK POST, STATING THAT THE TEST RESULTS THEY RECEIVED WERE WRONG. DUE TO THE LACK OF INFORMATION PROVIDED BY THE CONSUMER, IT IS UNCLEAR WHETHER THE CONSUMER RECEIVED A FALSE NEGATIVE OR FALSE POSITIVE RESULT. THEREFORE, ORASURE TECHNOLOGIES, INC. HAS CHOSEN TO REPORT THE CONSUMERS COMPLAINT, AS BOTH A FALSE NEGATIVE AND FALSE POSITIVE RESULT. REFER TO MDR 3004142665-2022-00033 FOR THE FALSE POSITIVE SUBMISSION. (B)(6)2022- CONSUMER POSTED A REVIEW ON FACEBOOK.COM. NO ADDITIONAL FOLLOW UP IS TO BE EXPECTED WITH THE COMPLAINT FILE, AND THE INCIDENT WILL BE CLOSED INTERNALLY.

    Additional Manufacturer Narrative · 0

    CONSUMER LEFT A COMMENT ON AN INTELISWAB FACEBOOK POST. NO ADDITIONAL FOLLOW UP IS TO BE EXPECTED WITH THE COMPLAINT FILE, AND THE INCIDENT WILL BE CLOSED INTERNALLY.

    Description of Event or Problem · 0

    CONSUMER LEFT A COMMENT ON AN INTELISWAB FACEBOOK POST STATING THEIR HOME TESTS WERE WRONG AND A WASTE OF TIME. FACEBOOK COMMENT HUDSON REGINA. 'MY HOME TEST WERE WRONG. WASTE OF TIME.'

    Description of Event or Problem · 0

    CONSUMER LEFT A COMMENT ON AN INTELISWAB FACEBOOK POST STATING THEIR HOME TESTS WERE WRONG AND A WASTE OF TIME. FACEBOOK COMMENT: (B)(6). 'MY HOME TEST WERE WRONG. WASTE OF TIME.'

    Description of Event or Problem · 0

    CONSUMER LEFT A COMMENT ON AN INTELISWAB FACEBOOK POST STATING THEIR HOME TESTS WERE WRONG AND A WASTE OF TIME. FACEBOOK COMMENT: (B)(6) 'MY HOME TEST WERE WRONG. WASTE OF TIME.'.

    Description of Event or Problem · 0

    CONSUMER LEFT A COMMENT ON AN INTELISWAB FACEBOOK POST STATING THEIR HOME TESTS WERE WRONG AND A WASTE OF TIME. FACEBOOK COMMENT: (B)(6). 'MY HOME TEST WERE WRONG. WASTE OF TIME.'

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2257533 INTELISWAB COVID-19 RAPID TEST INTELISWAB QKP ORASURE TECHNOLOGIES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown