BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHECK-IT

    MDR report key: 14481542 · Received May 23, 2022

    Report

    Report Number
    3016521623-2022-00199
    Event Type
    Malfunction
    Date Received
    May 23, 2022
    Date of Event
    April 30, 2022
    Report Date
    May 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 HAS NOT BEEN RETURNED. THEREFORE, A DHR REVIEW WAS COMPLETED FOR KIT LOT NUMBER K08A111803224M1 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 THESE LOTS. THERE ARE TWO SIMILAR COMPLAINTS (B)(4) WITH ALLEGED FALSE POSITIVES REPORTED FROM TWO DIFFERENT CUSTOMERS FROM THE SAME KIT LOT NUMBER K08A111803224M1. AN INVESTIGATION INTO THESE COMPLAINTS HAVE BEEN REVIEWED TO OBTAIN ADDITIONAL INFORMATION. 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 (B)(4) (LABEL CLAIM)/(B)(4) (INTERNAL WARNING LIMIT). ACCORDING TO THE FAILURE RATE (B)(4) FOR THIS LOT, THE NUMBER OF FALSE POSITIVES (18-TOTAL FPS TOTAL REPORTED FOR COMPLAINT (B)(4) KIT LOT # K08A111803224M1) AND TOTAL LOT QUANTITY (B)(4) IS UNDER OUR EXPECTED THRESHOLD. LUCIRA HEALTH WILL CONTINUE TO MONITOR TRENDS RELATED TO FALSE POSITIVE RESULTS IN ACCORDANCE WITH POST-MARKET SURVEILLANCE PROCESS. DHR REVIEW KIT LOT# K08A111803224M1: SAMPLE VIAL LOT DHR REVIEW: 2202252, 2202495, 2203046, 2202460, 2203075, 2203022, 2203200 (ASSOCIATED INTERNAL LOT # 220124-2E, 220124-2U, 220124-5G, 220124-5N, 220124-5P, 220124-5U, 220124-8R) TEST LOT DHRS REVIEW: 2203135, 2203141, 2203143, 2203142, 2203141, 2203142, 2203192 (ASSOCIATED INTERNAL LOT # 220305-6G220305-6N, 220305-6S, 220305-6O, 220305-6L, 220305-6Q, 220305-6W) 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.

    Description of Event or Problem · 0

    ONE DEVICE REPORTED AS HAVING A FALSE POSITIVE RESULT. THE COMPLAINANT REPORTED THAT AN INDIVIDUAL TOOK A LUCIRA TEST WITH A POSITIVE RESULT. AFTERWARDS, THE INDIVIDUAL FOLLOWED-UP WITH TWO ADDITIONAL LUCIRA TESTS WITH NEGATIVE RESULTS FOR CONFIRMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1518481 CHECK-IT COVID-19 TEST KIT QJR LUCIRA HEALTH, INC. K08A111803224M1

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other