BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHECK-IT

    MDR report key: 15189370 · Received August 8, 2022

    Report

    Report Number
    3016521623-2022-00271
    Event Type
    Malfunction
    Date Received
    August 8, 2022
    Date of Event
    July 25, 2022
    Report Date
    August 4, 2022
    Manufacturer
    LUCIRA HEALTH, INC.
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT HAS NOT BEEN RETURNED. THE CUSTOMER PROVIDED INFORMATION PERTAINING TO TWO KIT LOT NUMBERS (K08A110401224M2 AND K08A111001223M2) REPORTED TO BE ASSOCIATED WITH THE ALLEGED FALSE POSITIVES. A REVIEW OF EXISTING CAPAS, SCARS AND NCMRS WERE COMPLETED AND THERE ARE NO PRIOR RECORDS RELATED TO "FALSE POSITIVE" FAILURE MODE FOR THESE LOTS. THERE ARE 0 ADDITIONAL COMPLAINTS FROM THIS CUSTOMER ASSOCIATED WITH A "FALSE POSITIVE" FAILURE MODE PER TRENDING REVIEW FOR KIT LOT NUMBER K08A110401224M2. HOWEVER, THERE IS ONE PREVIOUS ALLEGED FALSE POSITIVE REPORTED FROM A DIFFERENT CUSTOMER: ((B)(4)/3016521623-2022-00162; RECEIPT DATE 04/15/2022), ASSOCIATED WITH KIT LOT NUMBER K08A111001223M2. A DHR REVIEW WAS CONDUCTED FOR TWO KIT LOT NUMBERS K08A110401224M2 AND K08A111001223M2. THERE WERE 0 DISCREPANCIES FOUND (ALL LOTS PASSED IN TOTAL PER THE SAMPLING PLAN). DHR REVIEW FOR KIT LOT NUMBER K08A110401224M2 : DHR REVIEW KIT LOT# K08A110401224M2: SAMPLE VIAL LOT DHR REVIEW: 2112203, 2112204, 2112287, 2112263, 2112322, 2112323, 2112321, 2112361, 2112323, 2112362, (ASSOCIATED INTERNAL LOT # 210762-2KI, 210762-2KJ, 211346.1-1B, 211346.1-1F, 211346.1-1R, 211346.1-1S, 211346.1-1T, 2113461-2I, 211346.1-1S, 2113461-2K). TEST LOT DHRS REVIEW: 2112221, 2112232, 2112270, 2112271, 2112271, 2112300, 2112326, 2112270, 2112315, 2112285, 2112285, 2112300, 2112302, 2112302, 2112302, 2112326, 2112315, 2112315, 2112349, 2112369, 2112369 (ASSOCIATED INTERNAL LOT # 210762-26E, 210762-26K, 211346.2-1D, 211346.2-1E, 211346.2-1G, 211346.2-1Q, 2113462-1R, 211346.2-1L, 211346.2-2R, 211346.2-1M, 211346.2-1N, 211346.2-1O, 2113462-1Z, 2113462-2B, 2113462-2D, 2113462-2F, 211346.2-2N, 211346.2-2P, 2113462-2V, 2113462-3K, 2113462-3P. DHR REVIEW FOR KIT LOT NUMBER K08A111001223M2 : SAMPLE VIAL LOT DHR REVIEW: 2111287, 2111309, 2111289, 2111290, 2111328, 2112037, 2112088, 2112288, 2112289, 2112295, 2112319, 2112291, 2112262 (ASSOCIATED INTERNAL LOT # 210762-2HE, 210762-2HK, 210762-2HL, 210762-2HO, 210762-2HR, 210762-2IG, 210762-2IZ, 211346.1-1I, 211346.1-1J, 211346.1-1K, 211346.1-1P, 211346.1-1D, 211346.1-1E). TEST LOT DHRS REVIEW: 2112301, 2112301, 2112301, 2112301, 2112327, 2112302, 2112326, 2112326, 2112326, 2112327, 2112315 (ASSOCIATED INTERNAL LOT # 2113462-1S, 2113462-1V, 2113462-1W, 2113462-1X, 2113462-1Y, 2113462-1Z, 2113462-2H, 2113462-2J, 2113462-2K, 2113462-2M, 211346.2-2O). BASED ON REVIEW OF THE PRODUCT'S FMEAS AND RISK ASSESSMENT DOCUMENTATION, FALSE POSITIVE TEST RESULTS ARE A KNOWN POSSIBLE OUTCOME REGARDING THIS ISSUE UNDER EVALUATION, REFER TO FMEA-001 AND FMEA-004. (B)(4). 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. LUCIRA HEALTH WILL CONTINUE TO MONITOR TRENDS RELATED TO FALSE POSITIVE RESULTS IN ACCORDANCE WITH POST-MARKET SURVEILLANCE PROCESS. 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 (B)(4) CHECK-IT.

    Description of Event or Problem · 0

    A COMPLAINT WAS REPORTED STATING, "MULTIPLE FALSE POSITIVE RESULTS" IN ASSOCIATION BETWEEN TWO KIT LOT NUMBERS (K08A110401224M2 AND K08A111001223M2). THE COMPLAINANT WAS CONTACTED TO PROVIDED ADDITIONAL INFORMATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1988049 CHECK-IT COVID-19 TEST KIT QJR LUCIRA HEALTH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Congenital Anomaly| O