BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHECK-IT

    MDR report key: 15173105 · Received August 5, 2022

    Report

    Report Number
    3016521623-2022-00269
    Event Type
    Malfunction
    Date Received
    August 5, 2022
    Date of Event
    July 22, 2022
    Report Date
    August 1, 2022
    Manufacturer
    LUCIRA HEALTH, INC.
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT HAS NOT BEEN RETURNED. THE CUSTOMER PROVIDED KIT LOT NUMBER INFORMATION FOR ONE OUT OF THE TWO ALLEGED FALSE POSITIVE DEVICES REPORTED. THEREFORE, A DHR REVIEW FOR ONE OF THE DEVICES ASSOCIATED WITH KIT LOT NUMBER K08A112203223M1 WAS COMPLETED 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 IS TWO SIMILAR COMPLAINTS (B)(4) WITH AN ALLEGED FALSE POSITIVE REPORT FROM TWO DIFFERENT CUSTOMERS ASSOCIATED WITH THE SAME KIT LOT NUMBER K08A112203223M1. 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 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# K08A112203223M1: SAMPLE VIAL LOT DHR REVIEW: 2203138 (ASSOCIATED INTERNAL LOT # 220124-4V) TEST LOT DHRS REVIEW: 2202448, 2202476, 2202475, 2202473, 2202476, 2202475, 2202474, 2202394, 2203073, 2203081, 2203072 (ASSOCIATED INTERNAL LOT # 220124-27U, 220124-30L, 220124-30I, 220124-30C, 220124-30K, 220124-30G, 220124-30F, 220124-12N, 220305-3E, 220305-3G, 220305-3C) A FAILURE ANALYSIS (FA) WAS CONDUCTED FOR KIT LOT # K08A112203223M1 ON (B)(6) 2022, ASSOCIATED WITH COMPLAINT 3016521623-2022-00165 THROUGH 3016521623-2022-00176 FOR FURTHER INVESTIGATION (ALL ASSOCIATED KIT LOT NUMBERS UNDERWENT FURTHER INVESTIGATION TESTING DUE TO AN ALLEGED FALSE POSITIVE REPORT). FAILURE ANALYSIS TESTING FOR KIT LOT# K08A112203223M1 RESULTS: LUCIRA HEALTH PULLED RETAINS ASSOCIATED WITH KIT LOT NUMBER K08A112203223M1 (50 TEST UNITS, 50 SAMPLE VIALS) FOR TESTING. THE TEST UNITS/SAMPLE VIALS WERE TESTED FOLLOWING WI162 (DEVICE LOT RELEASED-NO TEMPLATE CONTROL (NTC) TESTING) SECTION 9.3. ALL RETAINED DEVICES PASSED WITHOUT ANY FALSE POSITIVE RESULTS. THEREFORE, KIT LOT NUMBER K08A112203223M1 PASSED THE RELEASE CRITERIA IN THE INTERNAL TESTING. 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.

    Description of Event or Problem · 0

    ONE DEVICE REPORTED AS HAVING AN ALLEGED FALSE POSITIVE RESULT. THE COMPLAINANT PERFORMED ONE LUCIRA TEST (MONDAY) WITH A POSTIVE RESULT. THE COMPLAINANT FOLLOWED-UP THE NEXT DAY WITH A PCR TEST AND A BINAX TEST WITH NEGATIVE RESULTS. THE CUSTOMER PERFORMED AN ADDITIONAL LUCIRA TEST WITH A POSITIVE RESULT (FRIDAY).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1468680 CHECK-IT COVID-19 TEST KIT QJR LUCIRA HEALTH, INC. K08A112203223M1

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other