BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUIDEL QUICKVUE AT-HOME OTC COVID-19 TEST

    MDR report key: 12812872 · Received November 12, 2021

    Report

    Report Number
    MW5105285
    Event Type
    Malfunction
    Date Received
    November 12, 2021
    Date of Event
    November 5, 2021
    Report Date
    November 9, 2021
    Manufacturer
    QUIDEL CORP.
    Product Code
    QKP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    QUIDEL QUICKVUE AT-HOME OTC COVID-19 TEST PRODUCED A FALSE POSITIVE COVID-19 RESULT ON MY SON ON (B)(6) 2021 - TEST STRIP SHOWED 2ND PINK LINE INDICATING A "POSITIVE"; HOWEVER, TEST STRIP WAS STREAKED WITH PINK COLOR. FALSE POSITIVE CONFIRMED VIA ADDITIONAL ANTIGEN TEST ON SAME DAY (BD VERITOR AT-HOME COVID-19 TEST TAKEN (B)(6) 2021 RECORDED NEGATIVE RESULT; FOLLOW-UP PCR TEST BIOFIRE 2.1 RESPIRATORY PANEL ON (B)(6) 2021 REPORTED NEGATIVE RESULT). FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1700158 QUIDEL QUICKVUE AT-HOME OTC COVID-19 TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP QUIDEL CORP. 3650018

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown