BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHECK-IT

    MDR report key: 13620611 · Received February 28, 2022

    Report

    Report Number
    3016521623-2022-00043
    Event Type
    Malfunction
    Date Received
    February 28, 2022
    Date of Event
    February 10, 2022
    Report Date
    February 25, 2022
    Manufacturer
    LUCIRA HEALTH, INC.
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT WAS NOT RETURNED. A DHR REVIEW OF THE ASSOCIATED KIT LOT NUMBER (K08A112812214M3) WAS 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. THE COMPLAINT RATE FOR FALSE POSITIVE IS UNDER THE EXPECTED THRESHOLD OF 2% (LABEL CLAIM)/1% (INTERNAL WARNING LIMIT). LUCIRA HEALTH WILL CONTINUE TO MONITOR TRENDS RELATED TO FALSE POSITIVE RESULTS IN ACCORDANCE WITH POST-MARKET SURVEILLANCE PROCESS. TEST LOT DHRS REVIEWED: 2112191, 2112232, 2112221, 2112188, 2112165, 2112174, 2112192, 2112233, 2112210, 2112208, 2112192 (ASSOCIATED INTERNAL LOT # 210762-25T, 210762-26F, 210762-26C, 210762-25Y, 210762-25C, 210762-24F, 210762-25E, 210762-26Z, 210762-25A, 210762-26X, 210762-26E, 210762-26V, 210762-24G, 210762-26U, 210762-27A, 210762-27F, 210762-26A, 210762-24G, 210762-25E, 210762-26D, 210762-26S) SAMPLE VIAL LOT DHRS REVIEWED: 2112231, 2112263, 2112204 (ASSOCIATED INTERNAL LOT #S 210762-2KN, 211346.1-1F, 210762-2KJ) BASED ON THE COMPLAINT REVIEW, NO HARM WAS REPORTED WITHIN THE COMPLAINT. 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 210196 CHECK-IT.

    Description of Event or Problem · 0

    ONE DEVICE REPORTED AS HAVING A FALSE POSITIVE RESULT. COMPLAINANT PERFORMED TWO ADDITIONAL TESTS AFTER THE POSITVE RESULT (1 LUCIRA TEST AND 1 PCR TEST) AND RECEIVED NEGATIVE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1148835 CHECK-IT COVID-19 TEST KIT QJR LUCIRA HEALTH, INC. K08A112812214M3

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other