BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELISWAB COVID-19 RAPID TEST

    MDR report key: 13177833 · Received January 6, 2022

    Report

    Report Number
    3004142665-2022-00004
    Event Type
    Malfunction
    Date Received
    January 6, 2022
    Date of Event
    November 2, 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
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4), 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 (B)(6) HAS BEEN OPENED FOR PAST AND FUTURE FP CASES. ON (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 REPORTED TWO FALSE POSITIVE RESULTS WERE RECEIVED AFTER USING THE INTELISWAB PRODUCT. CONSUMER STATED THEY RECEIVED NEGAITIVE RESULTS FROM A DRIVE THRU TESTING CENTER. COMPLAINT WAS RECEIVED FROM INTELISWAB.COM, SEE BELOW: FULL NAME (B)(6). COUNTRY: UNITED STATES. SELECT YOUR ORGANIZATION TYPE OR USE: CONSUMER/PERSONAL USE. COMMENTS: I RECENTLY HAD TWO POSITIVES OUT OF TWO SEPARATE KIDS THIS PAST WEEK. I'M CONCERNED BECAUSE I WENT DOWN TO MY DOCTORS AND DID THEIR DRIVE-THROUGH TESTING FOR CONFIRMATION AND THAT TEST CAME BACK NEGATIVE. SO I'M VERY CURIOUS TO KNOW WHETHER OR NOT YOUR TEST IS ACCURATE. CAN SOMEBODY PLEASE CALL ME TO DISCUSS. ALSO IS THERE A LIKELIHOOD THAT I HAVE BEEN GIVEN A FALSE POSITIVE. WHICH WOULD SEEM STRANGE CONSIDERING THAT I HAVE TAKEN AT LEAST A DOZEN OF YOUR TESTS OVER THE LAST FEW MONTHS AND HAVE NEVER HAD A POSITIVE. THIS TIME I'M SYMPTOMATIC AND I'VE HAD TWO POSITIVES FROM TWO DIFFERENT BOXES. BUT THAT IS NOT CORRELATING WITH THE DOCTORS OFFICE. PLEASE CONTACT ME BACK THANK YOU.

    Description of Event or Problem · 0

    CONSUMER REPORTED TWO FALSE POSITIVE RESULTS WERE RECEIVED AFTER USING THE INTELISWAB PRODUCT. CONSUMER STATED THEY RECEIVED NEGATIVE RESULTS FROM A DRIVE THRU TESTING CENTER. COMPLAINT WAS RECEIVED FROM INTELISWAB.COM, SEE BELOW: (B)(6). SELECT YOUR ORGANIZATION TYPE OR USE: CONSUMER/PERSONAL USE COMMENTS: I RECENTLY HAD TWO POSITIVES OUT OF TWO SEPARATE KIDS THIS PAST WEEK. I'M CONCERNED BECAUSE I WENT DOWN TO MY DOCTORS AND DID THEIR DRIVE-THROUGH TESTING FOR CONFIRMATION AND THAT TEST CAME BACK NEGATIVE. SO I'M VERY CURIOUS TO KNOW WHETHER OR NOT YOUR TEST IS ACCURATE. CAN SOMEBODY PLEASE CALL ME TO DISCUSS. ALSO IS THERE A LIKELIHOOD THAT I HAVE BEEN GIVEN A FALSE POSITIVE. WHICH WOULD SEEM STRANGE CONSIDERING THAT I HAVE TAKEN AT LEAST A DOZEN OF YOUR TESTS OVER THE LAST FEW MONTHS AND HAVE NEVER HAD A POSITIVE. THIS TIME I'M SYMPTOMATIC AND I'VE HAD TWO POSITIVES FROM TWO DIFFERENT BOXES. BUT THAT IS NOT CORRELATING WITH THE DOCTORS OFFICE. PLEASE CONTACT ME BACK THANK YOU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1050141 INTELISWAB COVID-19 RAPID TEST INTELISWAB QKP ORASURE TECHNOLOGIES INC. 0006685482

    Patients

    Seq Age Sex Outcome Treatment
    1 Male