BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHECK-IT

    MDR report key: 13308819 · Received January 20, 2022

    Report

    Report Number
    3016521623-2022-00007
    Event Type
    Malfunction
    Date Received
    January 20, 2022
    Date of Event
    December 28, 2021
    Report Date
    January 20, 2022
    Manufacturer
    LUCIRA HEALTH, INC.
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT WAS NOT RETURNED. A DHR REVIEW (DHR 2110133 SAMPLE VIAL LOT (INTERNAL LOT# 210762-2BQ) AND DHR 2111039 TEST LOT (INTERNAL LOT # 210762-13D) OF THE ASSOCIATED KIT LOT NUMBER (K08A111111213M1) 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) CHECK-IT.

    Description of Event or Problem · 0

    ONE DEVICE REPORTED AS HAVING A FALSE POSITIVE RESULT. COMPLAINANT PERFORMED ADDITIONAL ANTIGEN SELF-TEST AND TWO PCR TESTS WITH NEGATIVE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    484919 CHECK-IT COVID-19 TEST KIT QJR LUCIRA HEALTH, INC. K08A111111213M1

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other