BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELISWAB COVID-19 RAPID TEST

    MDR report key: 13177451 · Received January 6, 2022

    Report

    Report Number
    3004142665-2022-00001
    Event Type
    Malfunction
    Date Received
    January 6, 2022
    Date of Event
    October 17, 2021
    Report Date
    January 6, 2022
    Manufacturer
    ORASURE TECHNOLOGIES INC.
    Product Code
    QKP
    PMA / PMN Number
    EUA210378
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6), REGULATORY MANAGER AT ORASURE TECHNOLOGIES INC., RECEIVED AN EMAIL FROM (B)(6) PH.D, STAFF FELLOW WITH THE FDA REQUESTING THAT ALL FALSE POSITIVE CASES OF INTELISWAB BE REPORTED TO THE FDA AS AN MDR IN ACCORDANCE WITH 21 CFR PART 803. PREVIOUSLY ORASURE TECHNOLOGIES WAS NOT SUBMITTING FP CASES AS AN MDR AS IT WAS A NON-REPORTABLE EVENT, THEREFORE PDR-22-0002 HAS BEEN OPENED FOR PAST AND FUTURE FP CASES. (B)(6) 2022- CONSUMER CALLED INTO THE CALL CENTER TO REPORT FP RESULT. NO FOLLOW UP IS TO BE EXPECTED WITH THE COMPLAINT FILE AND THE INCIDENT WILL BE CLOSED INTERNALLY.

    Additional Manufacturer Narrative · 0

    (B)(4), REGULATORY MANAGER AT ORASURE TECHNOLOGIES INC., RECEIVED AN EMAIL FROM (B)(4)STAFF FELLOW WITH THE FDA REQUESTING THAT ALL FALSE POSITIVE CASES OF INTELISWAB BE REPORTED TO THE FDA AS AN MDR IN ACCORDANCE WITH 21 CFR PART 803. PREVIOUSLY ORASURE TECHNOLOGIES WAS NOT SUBMITTING FP CASES AS AN MDR AS IT WAS A NON-REPORTABLE EVENT, THEREFORE (B)(4) HAS BEEN OPENED FOR PAST AND FUTURE FP CASES.

    Description of Event or Problem · 0

    CONSUMER STATED SHE PURCHASED THE INTELISWAB TEST AT A LOCAL DRUG STORE ,BECAUSE SHE HAS TO TEST WEEKLY FOR WORK. CONSUMER STATED SHE PERFORMED THE TEST ON (B)(6) 2021 AND RECEIVED A POSITIVE TEST RESULT. CONSUMER THEN CALLED HER DOCTOR AND HAD A PCR TEST PERFORMED ON (B)(6) 2021. CONSUMER STATED SHE GOT THE TEST RESULTS BACK ON (B)(6) 2021 AND THE RESULTS WERE NEGATIVE.

    Description of Event or Problem · 0

    CONSUMER STATED SHE PURCHASED THE INTELISWAB TEST AT A LOCAL DRUG STORE ,BECAUSE SHE HAS TO TEST WEEKLY FOR WORK. CONSUMER STATED SHE PERFORMED THE TEST ON (B)(6) 2021 AND RECEIVED A POSITIVE TEST RESULT. CONSUMER THEN CALLED HER DOCTOR AND HAD A PCR TEST PERFORMED ON (B)(6) 2021. CONSUMER STATED SHE GOT THE TEST RESULTS BACK ON (B)(6) 2021 AND THE RESULTS WERE NEGATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1050140 INTELISWAB COVID-19 RAPID TEST INTELISWAB QKP ORASURE TECHNOLOGIES INC. 0006685477

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Female