BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICKVUE HOME COVID TEST KIT

    MDR report key: 13395105 · Received January 28, 2022

    Report

    Report Number
    MW5107084
    Event Type
    Malfunction
    Date Received
    January 28, 2022
    Date of Event
    December 14, 2021
    Report Date
    January 28, 2022
    Manufacturer
    QUIDEL CORP.
    Product Code
    QKP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NE, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    REPORTER CALLED ON BEHALF OF HER HUSBAND TO REPORT A PRODUCT ISSUE INVOLVING A QUICKVUE HOME COVID-19 TEST KIT. REPORTER STATED THAT HER HUSBAND TOOK A QUICKVUE HOME COVID TEST ON (B)(6) 2021 AND RECEIVED A FALSE POSITIVE RESULT. REPORTER STATED HER HUSBAND TOOK A PCR TEST THE FOLLOWING DAY, AND 3 DAYS LATER FOUND OUT THE RESULT WAS NEGATIVE FOR COVID. REPORTER STATED THAT DUE TO HIM SHOWING SOME MILD SYMPTOMS AFTER THE FALSE POSITIVE RESULT ON (B)(6), HE HAD AN ANTIBODY INFUSION JUST IN CASE. REPORTER ALSO STATED THAT THERE WAS DEVICE INFORMATION ON THE INSIDE TRAY OF THE TEST KIT THAT WAS DIFFERENT FROM THE DEVICE INFORMATION ON THE OUTSIDE BOX. THE DEVICE INFORMATION FROM THE INSIDE TRAY OF THE DEVICE WAS: LOT # N112103, REF1493200, AND EXP 2023-09-21. REPORTER SAID THIS WAS VERY CONFUSING AS TO WHY THERE WOULD BE DIFFERENT DEVICE INFORMATION ON THE OUTSIDE OF THE BOX AND THE INSIDE CONTENTS. REPORTER STATED SHE DID CONTACT THE MFR AND WAS GIVEN CASE #:(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1403193 QUICKVUE HOME COVID TEST KIT CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP QUIDEL CORP. F40101

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Other