BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUCIRA BY PFIZER COVID-19 & FLU HOME TEST

    MDR report key: 19930517 · Received August 6, 2024

    Report

    Report Number
    MW5158047
    Event Type
    Injury
    Date Received
    August 6, 2024
    Date of Event
    August 2, 2024
    Report Date
    August 2, 2024
    Manufacturer
    PFIZER INC.
    Product Code
    QLT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    USED THE PFIZER TEST KIT "LUC-12000" AND IT PRODUCED AN INDICATION OF "INVALID RESULT". I CONTACTED THEIR CUSTOMER SUPPORT AND WAS TOLD BY THE OPERATOR (B)(4) AND THE SUPERVISOR "(B)(4)" THAT THEY WOULD NOT REPLACE THE TEST UNTIL 8/7/2024 BECAUSE THEY ARE UPGRADING THEIR SYSTEMS. REF #: LUC12000, LOT #: K10A1101012233M7, EXP: 2025-06-17, TEST KIT #: 3A4K3M3D.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1342887 LUCIRA BY PFIZER COVID-19 & FLU HOME TEST COVID-19 MULTI-ANALYTE RESPIRATORY PANEL NUCLEIC ACID DEVICES QLT PFIZER INC. LUC12000 K10A1101012233M7

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Disability