BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELISWAB COVID-19 RAPID TEST

    MDR report key: 13190628 · Received January 7, 2022

    Report

    Report Number
    3004142665-2022-00002
    Event Type
    Malfunction
    Date Received
    January 7, 2022
    Date of Event
    October 21, 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 Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6), REGULATORY MANAGER AT (B)(6), 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)(4) HAS BEEN OPENED FOR PAST AND FUTURE FP CASES.

    Additional Manufacturer Narrative · 0

    (B)(6), REGULATORY MANAGER AT ORASURE TECHNOLOGIES INC., RECEIVED AN EMAIL FROM (B)(6), 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 LEFT A REVIEW ON WALGREENS.COM. NO 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 REVIEW ON WALGREENS.COM STATING THEY RECEIVED A POSITIVE RESULT WITH INTELISWAB, HOWEVER TESTED NEGATIVE THE NEXT DAY AT URGENT CARE WITH A RAPID AND PCR. WALGREENS.COM REVIEW, KARMA999 · 2 MONTHS AGO. FALSE POSITIVE ALMOST COST ME MY FLIGHT I WAS NERVOUS ABOUT TAKING MY PCR TEST FOR AN UPCOMING FLIGHT SO I GOT THE ONLY AT HOME TEST THAT WALGREENS HAD AVAILABLE AT THE TIME. TOOK BOTH TESTS MYSELF, A FEW DAYS APART. FOLLOWED DIRECTIONS EXACTLY...BOTH TESTS CAME UP UNDENIABLY POSITIVE. I WAS NOT (NOR HAVE I BEEN) EXHIBITING ANY SYMPTOMS. THEN, AS I WAS WORRYING, WONDERING WHAT I WAS GOING TO DO, I LOOKED AT THE BOX MORE CAREFULLY...THIS TEST IS NOT APPROVED BY THE FDA NOR DOES IT EVEN SAY PCR TEST ANYWHERE ON THE BOX. I DECIDED TO TAKE THE LEAP OF FAITH (REGARDLESS OF THE 2 AT HOME TESTS' RESULTS) AND GOT THE FULL BLOWN PROFESSIONALLY DONE DRIVE THROUGH PCR TEST (ALSO THROUGH WALGREENS). SO VERY GLAD I DID. MY PROFESSIONAL TEST ACTUALLY CAME BACK NEGATIVE (NO VIRUS DETECTED) AND I WAS ABLE TO TAKE MY FLIGHT. I WOULD NOT RECOMMEND THIS TEST TO ANYONE.

    Description of Event or Problem · 0

    CONSUMER LEFT A REVIEW ON WALGREENS.COM STATING THEY RECEIVED A POSITIVE RESULT WITH INTELISWAB, HOWEVER TESTED NEGATIVE THE NEXT DAY AT URGENT CARE WITH A RAPID AND PCR. WALGREENS.COM REVIEW. KARMA999 · 2 MONTHS AGO. FALSE POSITIVE ALMOST COST ME MY FLIGHT. I WAS NERVOUS ABOUT TAKING MY PCR TEST FOR AN UPCOMING FLIGHT SO I GOT THE ONLY AT HOME TEST THAT WALGREENS HAD AVAILABLE AT THE TIME. TOOK BOTH TESTS MYSELF, A FEW DAYS APART. FOLLOWED DIRECTIONS EXACTLY...BOTH TESTS CAME UP UNDENIABLY POSITIVE. I WAS NOT (NOR HAVE I BEEN) EXHIBITING ANY SYMPTOMS. THEN, AS I WAS WORRYING, WONDERING WHAT I WAS GOING TO DO, I LOOKED AT THE BOX MORE CAREFULLY...THIS TEST IS NOT APPROVED BY THE FDA NOR DOES IT EVEN SAY PCR TEST ANYWHERE ON THE BOX. I DECIDED TO TAKE THE LEAP OF FAITH (REGARDLESS OF THE 2 AT HOME TESTS' RESULTS) AND GOT THE FULL BLOWN PROFESSIONALLY DONE DRIVE THROUGH PCR TEST (ALSO THROUGH WALGREENS). SO VERY GLAD I DID. MY PROFESSIONAL TEST ACTUALLY CAME BACK NEGATIVE (NO VIRUS DETECTED) AND I WAS ABLE TO TAKE MY FLIGHT. I WOULD NOT RECOMMEND THIS TEST TO ANYONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1862140 INTELISWAB COVID-19 RAPID TEST INTELISWAB QKP ORASURE TECHNOLOGIES INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown