BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHECK-IT

    MDR report key: 15035094 · Received July 16, 2022

    Report

    Report Number
    3016521623-2022-00257
    Event Type
    Malfunction
    Date Received
    July 16, 2022
    Date of Event
    June 28, 2022
    Report Date
    July 15, 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 HAS NOT BEEN RETURNED. THEREFORE, A DHR REVIEW WAS COMPLETED FOR KIT LOT NUMBER K08A113001223M2 WITH 0 DISCREPANCIES FOUND (ALL LOTS PASSED IN TOTAL PER THE SAMPLING PLAN). 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. THERE ARE 0 ADDITIONAL COMPLAINTS FROM THIS CUSTOMER ASSOCIATED WITH A "FALSE POSITIVE" FAILURE MODE, PRIOR TO THE REPORTED RECEIPT DATE OF JUNE 28, 2022. (B)(4). DHR REVIEW KIT LOT# K08A113001223M2: SAMPLE VIAL LOT DHR REVIEW: 2201018, 2201020 (ASSOCIATED INTERNAL LOT # 2113461-3M, 3O) TEST LOT DHRS REVIEW: 2201188, 2201186, 2201188, 2201186, 2201189, 2201180 (ASSOCIATED INTERNAL LOT # 220008-7B, 4O, 7D, 4P, 7L, 7F) 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. A SUPPLEMENTAL REPORT WILL BE FILED IF ANY FURTHER INVESTIGATION AND/OR ADDITIONAL INFORMATION IS OBTAINED. BASED ON THE COMPLAINT REVIEW, NO HARM WAS REPORTED WITHIN THE COMPLAINT. THIS DEVICE IS MARKETED UNDER EUA 210196 CHECK-IT.

    Description of Event or Problem · 0

    ONE DEVICE REPORTED AS HAVING AN ALLEGED FALSE POSITIVE RESULT. COMPLAINANT PERFORMED A BINAX (ANTIGEN) TEST 35 MINUTES AFTERWARDS AND TOOK A PCR TEST ONE HOUR LATER. THE BINAX AND PCR TEST RESULTS WERE BOTH NEGATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2892505 CHECK-IT COVID-19 TEST KIT QJR LUCIRA HEALTH, INC. K08A113001223M2

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other