BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHECK-IT

    MDR report key: 13458074 · Received February 4, 2022

    Report

    Report Number
    3016521623-2022-00031
    Event Type
    Malfunction
    Date Received
    February 4, 2022
    Date of Event
    January 21, 2022
    Report Date
    February 4, 2022
    Manufacturer
    LUCIRA HEALTH, INC.
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT WAS NOT RETURNED. A DHR REVIEW OF THE ASSOCIATED KIT LOT NUMBER (K08A01091021BD1) WERE COMPLETED, AND 0 DISCREPANCIES WERE FOUND. A REVIEW OF EXISTING CAPAS, SCARS AND NCMRS WERE COMPLETED AND THERE ARE NO PRIOR RECORDS RELATED TO FALSE POSITIVE FAILURE MODE FOR THIS LOT NOR ANY PREVIOUS COMPLAINTS FROM THIS CUSTOMER ASSOCIATED WITH FALSE POSITIVE RESULT ISSUES PRIOR TO RECEIVED DATE OF (B)(6) 2022. LUCIRA HEALTH WILL CONTINUE TO MONITOR TRENDS RELATED TO FALSE POSITIVE RESULTS. SAMPLE VIAL LOT DHR REVIEWED: 2110005 (ASSOCIATED INTERNAL LOT # 210762-2JJJ) TEST LOT DHRS REVIEWED: 2109354 AND 2110010 (ASSOCIATED INTERNAL LOT #S 210762-7K AND 210762-7O) BASED ON THE LIMITED INFORMATION AVAILABLE, ROOT CAUSE CANNOT BE DETERMINED. 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 AN ADDITIONAL PCR TEST WITH A NEGATIVE RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1008120 CHECK-IT COVID-19 TEST KIT QJR LUCIRA HEALTH, INC. K08A01091021BD1

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other