BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELLUME COVID-19 HOME TEST

    MDR report key: 13048279 · Received December 20, 2021

    Report

    Report Number
    3014862188-2021-01219
    Event Type
    Malfunction
    Date Received
    December 20, 2021
    Date of Event
    October 7, 2021
    Report Date
    November 30, 2021
    Manufacturer
    ELLUME LIMITED
    Product Code
    QKP
    PMA / PMN Number
    EUA203011
    Removal / Correction Number
    88801
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    REPORT REQUIRED BY FDA FOR EUA. INVESTIGATION NOT COMPLETE AT TIME OF REPORT. FOLLOW-UP REPORT TO FOLLOW COMPLETION OF INVESTIGATION. RELATES TO (B)(6) , (B)(6) (3014862188-2021-01217, 8: TESTS 1, 2, OF 3). THIS IS A RETROSPECTIVE REPORT DUE TO CHALLENGES IMPLEMENTING ESG.

    Description of Event or Problem · 0

    USER REPORTED 3 FALSE POSITIVE RESULTS. NEGATIVE BY PCR. THIS IS REPORT 3 OF 3.

    Description of Event or Problem · 0

    USER REPORTED 3 FALSE POSITIVE RESULTS. NEGATIVE BY PCR. THIS IS REPORT 3 OF 3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1941015 ELLUME COVID-19 HOME TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP ELLUME LIMITED 21139-004

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown