BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELISWAB COVID-19 RAPID TEST

    MDR report key: 13098921 · Received December 28, 2021

    Report

    Report Number
    3004142665-2021-00022
    Event Type
    Malfunction
    Date Received
    December 28, 2021
    Date of Event
    December 26, 2021
    Report Date
    December 28, 2021
    Manufacturer
    ORASURE TECHNOLOGIES INC.
    Product Code
    QKP
    PMA / PMN Number
    EUA210378
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    NO FOLLOWUP IS TO BE EXPECTED WITH THE COMPLAINT FILE AND THE INCIDENT WILL BE CLOSED INTERNALLY.

    Description of Event or Problem · 0

    CONSUMER REPORTED A FALSE NEGATIVE RESULT WAS RECEIVED AFTER USING THE INTELISWAB PRODUCT. CONSUMER STATED THEY RECEIVED POSITIVE RESULTS USING TWO OTHER RAPID TEST BRANDS BUT RECEIVED A NEGATIVE RESULT USING INTELISWAB. 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 PURCHASED 2 SETS OF THE INTELISWAB COVID TESTS AND THE TEST CAME BACK NEGATIVE EVEN THOUGH I QM POSITIVE FOR COVID. I FEEL LIKE THE SHAPE OF THE SWAB IS TOO AWKWARD AND SHARP TO GET A GOOD READING IN NOSE. I WOULD LIKE REPLACEMENT TESTS OR A REFUND. ORIGINAL REF: HTTPS://WWW.GOOGLE.COM/. LAST TOUCH REF: HTTPS://WWW.GOOGLE.COM/. ORGANIC SOURCE: HTTPS://WWW.GOOGLE.COM/.

    Description of Event or Problem · 0

    CONSUMER REPORTED A FALSE NEGATIVE RESULT WAS RECEIVED AFTER USING THE INTELISWAB PRODUCT. CONSUMER STATED THEY RECEIVED POSITIVE RESULTS USING TWO OTHER RAPID TEST BRANDS BUT RECEIVED A NEGATIVE RESULT USING INTELISWAB. COMPLAINT WAS RECEIVED FROM INTELISWAB.COM, SEE BELOW: FULL NAME (B)(6). SELECT YOUR ORGANIZATION TYPE OR USE: CONSUMER/PERSONAL USE. COMMENTS: I PURCHASED 2 SETS OF THE INTELISWAB COVID TESTS AND THE TEST CAME BACK NEGATIVE EVEN THOUGH I QM POSITIVE FOR COVID. I FEEL LIKE THE SHAPE OF THE SWAB IS TOO AWKWARD AND SHARP TO GET A GOOD READING IN NOSE. I WOULD LIKE REPLACEMENT TESTS OR A REFUND. ORIGINAL REF: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2000764 INTELISWAB COVID-19 RAPID TEST INTELISWAB QKP ORASURE TECHNOLOGIES INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown