BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALL IN ONE

    MDR report key: 12602594 · Received October 9, 2021

    Report

    Report Number
    3016521623-2021-00010
    Event Type
    Malfunction
    Date Received
    October 9, 2021
    Report Date
    November 29, 2021
    Manufacturer
    LUCIRA HEALTH, INC.
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    A DHR REVIEW OF THE ASSOCIATED KIT LOT WAS COMPLETED AND NO DISCREPANCIES WERE FOUND. A REVIEW OF EXISTING CAPA, SCAR AND NCMRS WAS COMPLETED AND THERE ARE NO PRIOR RECORDS RELATED TO FALSE POSITIVE FAILURE MODE FOR THIS LOT. A ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME. THERE ARE 3 POTENTIAL ROOT CAUSES LISTED BELOW, HOWEVER, THESE CANNOT BE CONFIRMED AS THE DEVICES WERE NOT RETURNED AND NO DISCREPANCIES WERE IDENTIFIED DURING REVIEW OF THE DHR AND EXISTING QUALITY RECORDS: ENVIRONMENTAL CONTAMINATION, LOW VIRAL LOAD, DEVICE FAILURE.

    Additional Manufacturer Narrative · 0

    THIS DEVICE IS MARKETED UNDER EMERGENCY USE AUTHORIZATION (EUA) 202920.

    Description of Event or Problem · 0

    TWO DEVICES WERE REPORTED AS HAVING FALSE POSITIVE RESULTS. COMPLAINT PERFORMED ADDITIONAL RT-PCR LAB TESTING RESULTING IN A NEGATIVE RESULT. THE COMPLAINT DEVICES WERE NOT RETURNED.

    Description of Event or Problem · 1

    THE COMPLAINT ALLEGES A (B)(6) RESULT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1500398 ALL IN ONE LUCIRA ALL IN ONE COVID-19 TEST KIT QJR LUCIRA HEALTH, INC.
    1500405 ALL IN ONE LUCIRA ALL IN ONE COVID-19 TEST KIT QJR LUCIRA HEALTH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown