BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHECK-IT

    MDR report key: 16728842 · Received April 12, 2023

    Report

    Report Number
    3016521623-2023-00397
    Event Type
    Malfunction
    Date Received
    April 12, 2023
    Date of Event
    April 10, 2023
    Report Date
    April 11, 2023
    Manufacturer
    LUCIRA HEALTH, INC.
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT HAS NOT BEEN RETURNED AND NO HARMS REPORTED. THEREFORE, A DHR REVIEW WAS COMPLETED FOR KIT LOT NUMBER K08A111104224M1 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 NEGATIVE FAILURE MODE FOR THIS LOT. THERE ARE 0 ADDITIONAL COMPLAINTS FROM THIS CUSTOMER, NOR ANY OTHER CUSTOMER ASSOCIATED WITH A FALSE NEGATIVE FAILURE MODE PRIOR TO THE REPORTED RECEIPT DATE OF (B)(6), 2023. THE COMPLAINT RATE FOR FALSE NEGATIVES IS UNDER THE EXPECTED THRESHOLD OF (B)(4)LABEL CLAIM (B)(4) INTERNAL WARNING LIMIT. LUCIRA HEALTH WILL CONTINUE TO MONITOR TRENDS RELATED TO FALSE NEGATIVE RESULTS IN ACCORDANCE WITH POST-MARKET SURVEILLANCE PROCESS. KIT LOT K08A111104224M1 DHR REVIEW REFERENCE: SAMPLE VIAL LOT DHR REVIEW: 2203438, 2202318, 2203506, 2203231, 2203332 ASSOCIATED INTERNAL LOT #220305-1J, 220124-1N, 220305-4D, 220124-7L, 220124-7R. TEST LOT DHRS REVIEW: 2203141, 2203143, 2203141, 2203269, 2203280, 2203282, 2203282, 2203381, 2203448, 2203478, 2203503, 2203503, 2203478, 2203502, 2203502, 2203502, 2203526, 2203577, 2203527, 2203527 ASSOCIATED INTERNAL LOT 220305-6N, 220305-6S, 220305-6M, 220305-12N, 220305-12U, 220305-12Y, 220305-12Z, 220305-18F, 220305-21J, 220305-24E, 220305-24L, 220305-24N, 220305-24G, 220305-24I, 220305-24K, 220305-24J, 220305-24X, 220305-27P, 220305-3H, 220305-3I. ADDITIONAL INFORMATION: A FALSE NEGATIVE OCCURS WHEN A TEST FAILS TO DETECT SARS COV 2 WHEN IT IS PRESENT IN A SAMPLE. SOMETIMES THIS HAPPENS WHEN THERE IS VERY LITTLE VIRUS PRESENT IN A SAMPLE. THE CHANCE OF GETTING A FALSE NEGATIVE RESULT WITH THE LUCIRA COVID 19 CHECK IT TEST KIT IS LOW. 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. THIS DEVICE IS MARKETED UNDER EUA (B)(4). CHECK IT.

    Description of Event or Problem · 0

    ONE DEVICE REPORTED AS HAVING ALLEGED FALSE NEGATIVE RESULT. THE COMPLAINANT TOOK ADDITIONAL TWO LUCIRA TESTS WITH POSITIVE RESULTS FOR CONFIRMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1144725 CHECK-IT COVID-19 TEST KIT QJR LUCIRA HEALTH, INC. K08A111104224M1

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other