BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICKVUE

    MDR report key: 12681423 · Received October 21, 2021

    Report

    Report Number
    MW5104831
    Event Type
    Malfunction
    Date Received
    October 21, 2021
    Date of Event
    October 18, 2021
    Report Date
    October 19, 2021
    Manufacturer
    QUIDEL CORP.
    Product Code
    QKP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    GAVE MY SON TWO HOME COVID TESTS AND BOTH CAME UP POSITIVE. TOOK HIM TO THE PEDIATRICIAN ON THE SAME DAY AS ONE OF THE POSITIVES. PEDIATRICIAN PCR WAS NEGATIVE. HOME TEST WAS POSITIVE. HOME KIT GAVE US TWO FALSE POSITIVES. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1567963 QUICKVUE CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP QUIDEL CORP. F40075
    1567964 QUICKVUE CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP QUIDEL CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR