BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELLUME COVID-19 HOME TEST

    MDR report key: 12960343 · Received December 7, 2021

    Report

    Report Number
    MW5105886
    Event Type
    Malfunction
    Date Received
    December 7, 2021
    Date of Event
    December 3, 2021
    Report Date
    December 4, 2021
    Manufacturer
    ELLUME LIMITED
    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

    YESTERDAY, MY HUSBAND USED THE ELLUME COVID-19 HOME TEST KIT WHICH GAVE HIM A POSITIVE RESULT. HE THEN WENT TO OUR URGENT CARE FACILITY WHICH DID A PCR TEST AND THE RESULT CAME BACK NEGATIVE. SO THE ELLUME TEST GAVE A FALSE POSITIVE. THE LOT NUMBER OF THE ELLUME COVID-19 HOME TEST WAS 21252-1, REF# M1014423; FOR COVID-19 TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1853053 ELLUME COVID-19 HOME TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP ELLUME LIMITED 21252-1

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male