BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHECK-IT

    MDR report key: 13308821 · Received January 20, 2022

    Report

    Report Number
    3016521623-2022-00006
    Event Type
    Malfunction
    Date Received
    January 20, 2022
    Date of Event
    January 4, 2022
    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 OF THE ASSOCIATED KIT LOT NUMBER (K08A112812214M1) 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 NEGATIVE FAILURE MODE FOR THIS LOT. TEST LOT DHRS: 2112156, 2112165, 2112043, 2112145, 2112174, 2112106, 2112192, 2112233, 2112232, 2111353, 2112202, 2112191 (INTERNAL LOT #S 210762-24X, 210762-25C, 210762-24Y, 210762-25B, 210762-23B, 210762-24W, 210762-24U, 210762-24H, 210762-24O, 210762-24J, 210762-25G, 210762-24V, 210762-24R, 210762-24F, 210762-24P, 210762-24T, 210762-27A, 210762-26K, 210762-24L, 210762-20K 210762-24S, 210762-27E, 210762-24A, 210762-26Z , 210762-25J, 210762-2KH, 210762-24G, 210762-25E, 210762-25Q). SAMPLE VIAL LOT DHRS: 2112121, 2112122, 2112203, 2112205 (INTERNAL LOT #S 210762-2JO, 210762-2JV, 210762-2JY, 210762-2JU, 210762-2JW, 210762-2KI, 210762-2JT, 210762-2KL, 210762-2JX, 211346.1-1B, 210762-2KM). FALSE NEGATIVE 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 NEGATIVE RESULT. COMPLAINANT RECEIVED A POSITIVE RESULT FROM A LUCIRA TEST. COMPLAINANTS SPOUSE RECEIVED A NEGATIVE RESULT FROM A LUCIRA TEST. BOTH INDIVIDUALS HAD THE SAME SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    484921 CHECK-IT COVID-19 TEST KIT QJR LUCIRA HEALTH, INC. K08A112812214M1

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other