BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHECK-IT

    MDR report key: 13773308 · Received March 15, 2022

    Report

    Report Number
    3016521623-2022-00074
    Event Type
    Malfunction
    Date Received
    March 15, 2022
    Date of Event
    March 2, 2022
    Report Date
    May 23, 2022
    Manufacturer
    LUCIRA HEALTH, INC.
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT HAS NOT BEEN RETURNED. A DHR REVIEW OF THE ASSOCIATED KIT LOT NUMBER (K08A111102224M1) WAS COMPLETED, AND 0 DISCREPANCIES WERE 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 NOR ANY PREVIOUS COMPLAINTS FROM THIS CUSTOMER ASSOCIATED WITH "FALSE POSITIVE" RESULTS PRIOR TO RECEIVED DATE OF (B)(6) 2022. 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. THE COMPLAINT RATE FOR "FALSE POSITIVE" IS UNDER THE EXPECTED THRESHOLD OF 2% (LABEL CLAIM) 1% (INTERNAL WARNING LIMIT). LUCIRA HEALTH WILL CONTINUE TO MONITOR TRENDS RELATED TO FALSE POSITIVE RESULTS IN ACCORDANCE WITH POST-MARKET SURVEILLANCE PROCESS. TEST LOT DHRS REVIEWED: 2202016, 2202015, 2202013, 2202014. (ASSOCIATED INTERNAL LOT #S 220008-16X, 220008-16T, 220008-16N, 220008-16M, 220008-16R, 220008-16O, 220008-16Q, 220008-16W, 220008-16U, 220008-16V). SAMPLE VIAL LOT DHRS REVIEWED: 2201252, 2201333, 2201155, 2201251, 2201214, 2201332, 2201213 (ASSOCIATED INTERNAL LOT #S 220008-2R, 220008-5B, 220008-2H, 220008-2Q, 220008-2K, 220008-5A, 220008-2J). 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 (B)(4) CHECK-IT.

    Additional Manufacturer Narrative · 0

    ON MARCH 02, 2022, THE CUSTOMER REPORTED 81 FALSE POSITIVES OUT OF 2,304 TESTS PERFORMED AT AN EVENT (3016521623-2022-00074 (24 OUT OF 81) REPORTED ALLEGED FALSE POSITIVE). THE CUSTOMER RETURNED 50 UN-OPENED KITS WITH LOT NUMBER K08A111102224M1 ON APRIL 01, 2022. A FAILURE ANALYSIS (FA) INVESTIGATION WAS CONDUCTED (FA1801). THE KITS WERE TESTED FOLLOWING (B)(6) (DEVICE LOT RELEASED-NO TEMPLATE CONTROL (NTC) TESTING) SECTION 9.3, TO DUPLICATE THE HIGH FALSE POSITIVE RATE REPORTED WITH THE RETURNED DEVICES. ALL RETURNED DEVICES PASSED WITHOUT ANY FALSE POSITIVE RESULTS. THEREFORE, LUCIRA HEALTH WAS UNABLE TO DUPLICATE THE HIGH RATE OF FALSE POSITIVES IN THE INTERNAL TESTING AND KIT LOT # K08A111102224M1 STILL PASSED THE RELEASE CRITERIA. COMPLAINT WAS NOT CONFIRMED. POTENTIAL ROOT CAUSE: THE POTENTIAL FALSE POSITIVE CAN BE ATTRIBUTABLE TO ALREADY ESTABLISHED ROOT CAUSES: LOW VIRAL LOAD, ENVIRONMENTAL CONTAMINATION, OR ASSAY FAILURE. SECTION H3 (CORRECTED FROM NO TO YES)-DEVICE EVALUATED BY MANUFACTURER? -YES. SECTION H6-TYPE OF INVESTIGATION (ADDITIONAL CODES ADDED): 4101- TESTING OF DEVICE FROM SAME LOT/BATCH RETURNED BY USER. 4110-TREND ANALYSIS.

    Description of Event or Problem · 0

    ONE DEVICE REPORTED AS HAVING A FALSE POSITIVE RESULT. THE COMPLAINANT MANAGES LARGE CONFERENCES AND CONCERTS WITH LIVE NATION. LUCIRA TEST KITS WERE SELF ADMINISTERED ON-SITE AT THE CONFERENCES. THE POSITIVE RESULT WAS CONFIRMED WITH THE FOLLOWING PROTOCOL, LUCIRA TEST=POSITIVE, LUCIRA TEST= POSITIVE, ANTIGEN=NEGATIVE, AND ONSITE PCR TEST USING EITHER ACCULA OR BIO MENE= NEGATIVE. THE PCR TEST CAME BACK WITH ZERO VIRAL LOAD (NEGATIVE RESULT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    822206 CHECK-IT COVID-19 TEST KIT QJR LUCIRA HEALTH, INC. K08A111102224M1

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other