BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELLUME COVID-19 HOME TEST

    MDR report key: 12842492 · Received November 19, 2021

    Report

    Report Number
    3014862-2021-00039
    Event Type
    Malfunction
    Date Received
    November 19, 2021
    Date of Event
    October 20, 2021
    Report Date
    December 21, 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.

    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. CORRECTED DATA: INITIAL REPORT IS CANCELLED DUE TO AN ERROR IN MFR NUMBER. REPORT WILL BE SUBMITTED UNDER THE CORRECTED REPORT NUMBER (3014862188-2021-00039) (10 DIGIT FEI-BASED).

    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.

    Description of Event or Problem · 0

    USER REPORTED CONFLICTING RESULTS ON SAME TEST. RECEIVED ONE POSITIVE AND ONE NEGATIVE. NO INFORMATION RELATING TO ANY RESULTS OR TYPES OF FOLLOW UP TESTING ON ALTERNATIVE PLATFORM PROVIDED.

    Description of Event or Problem · 0

    USER REPORTED CONFLICTING RESULTS ON SAME TEST. RECEIVED ONE POSITIVE AND ONE NEGATIVE. NO INFORMATION RELATING TO ANY RESULTS OR TYPES OF FOLLOW UP TESTING ON ALTERNATIVE PLATFORM PROVIDED.

    Description of Event or Problem · 0

    USER REPORTED CONFLICTING RESULTS ON SAME TEST. RECEIVED ONE POSITIVE AND ONE NEGATIVE. NO INFORMATION RELATING TO ANY RESULTS OR TYPES OF FOLLOW UP TESTING ON ALTERNATIVE PLATFORM PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1746413 ELLUME COVID-19 HOME TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP ELLUME LIMITED PF03M-H

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown