BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALL-IN-ONE

    MDR report key: 13308823 · Received January 20, 2022

    Report

    Report Number
    3016521623-2022-00009
    Event Type
    Malfunction
    Date Received
    January 20, 2022
    Date of Event
    December 30, 2021
    Report Date
    January 20, 2022
    Manufacturer
    LUCIRA HEALTH, INC.
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT WAS NOT RETURNED. A DHR REVIEW (DHR SAMPLE VIAL LOT #: 2107044. (INTERNAL LOT#: (200819-8B) AND DHR TEST LOT#: 2106075 (INTERNAL LOT #: 210348-3Y) OF THE ASSOCIATED KIT LOT NUMBER (K07A113107214M2) WAS COMPLETED, AND 0 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. FALSE POSITIVE IS A KNOWN POSSIBLE OUTCOME FOR A VERY SMALL PERCENTAGE OF CASES. ROOT CAUSE CANNOT BE DETERMINED BASED ON THE INFORMATION AVAILABLE. POTENTIAL ROOT CAUSES INCLUDE BUT ARE NOT LIMITED TO: ENVIRONMENTAL CONTAMINATION, LOW VIRAL LOAD, AND/OR DEVICE FAILURE. THIS DEVICE IS MARKETED UNDER EUA (B)(4) ALL-IN-ONE.

    Description of Event or Problem · 0

    ONE DEVICE REPORTED AS HAVING A FALSE POSITIVE RESULT. COMPLAINANT PERFORMED AN ADDITIONAL PCR TEST WITH A NEGATIVE RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    484923 ALL-IN-ONE COVID-19 TEST KIT QJR LUCIRA HEALTH, INC. K07A113107214M2

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other