BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHECK-IT

    MDR report key: 13458238 · Received February 4, 2022

    Report

    Report Number
    3016521623-2022-00013
    Event Type
    Malfunction
    Date Received
    February 4, 2022
    Date of Event
    January 14, 2022
    Report Date
    January 28, 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 OF SAMPLE VIAL LOT #S AND TEST LOT #S OF THE ASSOCIATED KIT LOT NUMBER (K08A11281221AM1) WAS COMPLETED, AND 0 DISCREPANCIES WERE FOUND. A REVIEW OF EXISTING CAPAS, SCARS AND NCMRS WAS COMPLETED AND THERE ARE NO PRIOR RECORDS RELATED TO FALSE POSITIVE FAILURE MODES FOR THIS LOT NOR ANY PREVIOUS COMPLAINTS FROM THIS CUSTOMER. SAMPLE VIAL LOT DHRS REVIEWED: 2112076, 2112202, 2112121, 2112154, 2112205, 2112287, 2112153, 2112227, 2112122, 2112123, 2112170 2112203 (ASSOCIATED INTERNAL LOT #S: 210762-2JT, 210762-2KH, 210762-2JO, 210762-2JW, 210762-2KL, 211346.1-1B 210762-2JV, 210762-2KM, 210762-2JU, 210762-2JX, 210762-2JY, 210762-2KI) TEST LOT DHRS REVIEWED: 2112145, 2112106, 2112156, 2112127, 2112120, 2112165, 2112174, 2112192, 2112233, 2112232, 2112145, 2112043, 2111353, 2112191 (ASSOCIATED INTERNAL LOT #S: 210762-24U, 210762-24P, 210762-24X, 210762-24A, 210762-24L 210762-24R, 210762-24J, 210762-25C, 210762-24F, 210762-24Y, 210762-25G, 210762-26Z, 210762-24S, 210762-26K, 210762-24G, 210762-24T, 210762-25B, 210762-27A, 210762-23B, 210762-20K, 210762-27E, 210762-25E, 210762-25Q, 210762-24V, 210762-24H, 210762-24W) 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 LUCIRA TEST WITH A NEGATIVE RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1337308 CHECK-IT COVID-19 TEST KIT QJR LUCIRA HEALTH, INC. K08A11281221AM1

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other