BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHECK-IT

    MDR report key: 15173102 · Received August 5, 2022

    Report

    Report Number
    3016521623-2022-00268
    Event Type
    Malfunction
    Date Received
    August 5, 2022
    Date of Event
    July 22, 2022
    Report Date
    September 26, 2022
    Manufacturer
    LUCIRA HEALTH, INC.
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT HAS NOT BEEN RETURNED. THEREFORE, A DHR REVIEW WAS COMPLETED FOR KIT LOT NUMBER K08A112803223M1 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 (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. DHR REVIEW KIT LOT# K08A112803223M1: SAMPLE VIAL LOT DHR REVIEW: 2203077, 2203076, 2203074, 2203078, 2203079, 2203075, 2203374.(ASSOCIATED INTERNAL LOT # 220124-5J, 220124-5Q, 220124-5O, 220124-5L, 220124-5M, 220124-5P, 220124-8J). TEST LOT DHRS REVIEW: 2203133, 2203114, 2203114, 2203144, 2203143, 2203196, 2203216, 2203196, 2203072, 2203072, 2203082, 2203072 (ASSOCIATED INTERNAL LOT # 220305-6I, 220305-6A, 220305-6B, 220305-6U, 220305-6T, 220305-9F, 220305-9R, 220305-9I, 220305-3A, 220305-3C, 220305-3J, 220305-3B). 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 (B)(4) CHECK-IT.

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2022, THE COMPLAINANT REPORTED ONE ALLEGED FALSE POSITIVE RESULT (3016521623-2022-00268; INITIAL 30-DAY MDR FILED 08/05/2022). THE COMPLAINANT RETURNED THE REPORTED DEVICE WITH KIT LOT NUMBER KIT LOT#K08A112803223M1 AND TEST KIT #3A3M4Y4B WHICH WAS RECEIVED ON AUGUST 15, 2022. A FAILURE ANALYSIS (FA2125) TEST WAS PERFORMED ON (B)(6) 2022. UPON ARRIVAL THE SAMPLE VIAL WAS STILL ENGAGED IN THE DEVICE. DOWNLOADED DATA FROM THE DEVICE SHOWED A POSITIVE RESULT WITH NO ERROR CODE OBSERVED. THE RETURNED DEVICE FUNCTIONED AS INTENDED. ADDITIONAL INFORMATION UPDATED: SECTION G6-FOLLOW-UP: 001 SECTION H2-DEVICE EVALUATION SECTION H3-DEVICE EVALUATED BY MANUFACTURER: YES SECTION H6- TYPE OF INVESTIGATION: 10-TESTING OF ACTUAL/SUSPECTED DEVICE SECTION H6- INVESTIGATION CONCLUSION: 67-NO PROBLEM DETECTED.

    Description of Event or Problem · 0

    ONE DEVICE REPORTED AS HAVING AN ALLEGED FALSE POSITIVE RESULT. THE COMPLAINANT TOOK A RAPID TEST (ANTIGEN) THAT SHOWED A NEGATIVE RESULT PRIOR TO PERFORMING A LUCIRA TEST (MOLECULAR) WITH A POSITIVE RESULT. WITHIN 1-4 HOURS AFTER PERFORMING THE LUCIRA TEST, THE COMPLAINANT TOOK A LAB PCR TEST WITH A NEGATIVE RESULT FOR CONFIRMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2275628 CHECK-IT COVID-19 TEST KIT QJR LUCIRA HEALTH, INC. K08A112803223M1

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other