BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICKVUE AT-HOME OTC COVID-19 TEST

    MDR report key: 13025458 · Received December 16, 2021

    Report

    Report Number
    MW5106117
    Event Type
    Malfunction
    Date Received
    December 16, 2021
    Date of Event
    December 13, 2021
    Report Date
    December 15, 2021
    Manufacturer
    QUIDEL CORP.
    Product Code
    QKP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    ADMINISTERED A QUICKVUE RAPID ANTIGEN TEST FROM QUIDEL AND GOT A POSITIVE RESULT. SAME-DAY (1 HOUR LATER) GOT THE WHOLE FAMILY TESTED FOR COVID BY PCR. ALL CAME BACK NEGATIVE. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1921498 QUICKVUE AT-HOME OTC COVID-19 TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. QKP QUIDEL CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 Female