BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUIDEL CORPORATION QUICKVUE AT-HOME OTC COVID-19 TEST

    MDR report key: 14117424 · Received April 14, 2022

    Report

    Report Number
    MW5108992
    Event Type
    Malfunction
    Date Received
    April 14, 2022
    Date of Event
    April 4, 2022
    Report Date
    April 12, 2022
    Manufacturer
    QUIDEL CORPORATION
    Product Code
    QKP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    MY COMPANY REQUIRES THAT I TAKE A WEEKLY HOME COVID TEST. I HAD NO SYMPTOMS BUT TESTED POSITIVE USING A QUICKVUE HOME TEST. I TESTED AGAIN ON (B)(6) 2022 USING THE SAME BRAND AND TESTED POSITIVE AGAIN. I THEN USED THE FREE GOVERNMENT TEST ON (B)(6) 2022 AND TESTED NEGATIVE AND THEN TESTED USING A DETECT TEST ON (B)(6) 2022 AND TESTED NEGATIVE. I WAITED AND TESTED AGAIN USING A QUICKVUE TEST ON (B)(6) 2022 AND IT WAS POSITIVE AGAIN. I SCHEDULED A PCR TEST AND TESTED ON (B)(6) 2022. IT WAS NEGATIVE. I RECEIVED THOSE RESULTS ON (B)(6) 2022. I TESTED AGAIN WITH A QUICKVUE TEST, KNOWING THAT I WAS NEGATIVE, AND ONCE AGAIN THE QUICKVUE TEST SHOWED POSITIVE. FOUR TIMES THE QUICKVUE TEST GAVE ME A FALSE POSITIVE RESULT IN LESS THAN ONE WEEK. I NEVER HAD SYMPTOMS. THE TESTS WERE FROM TWO DIFFERENT BOXES AND I FOLLOWED THE INSTRUCTIONS EXACTLY. THIS IS VERY CONCERNING. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1907214 QUIDEL CORPORATION QUICKVUE AT-HOME OTC COVID-19 TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP QUIDEL CORPORATION COVID 19 TEST 154097
    1907215 QUIDEL CORPORATION QUICKVUE AT-HOME OTC COVID-19 TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP QUIDEL CORPORATION COVID 19 TEST 154097
    1907216 QUIDEL CORPORATION QUICKVUE AT-HOME OTC COVID-19 TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP QUIDEL CORPORATION COVID 19 TEST 154097
    1907217 QUIDEL CORPORATION QUICKVUE AT-HOME OTC COVID-19 TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP QUIDEL CORPORATION COVID 19 TEST 154097

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Female Other