BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHECK-IT

    MDR report key: 14314253 · Received May 7, 2022

    Report

    Report Number
    3016521623-2022-00172
    Event Type
    Malfunction
    Date Received
    May 7, 2022
    Date of Event
    April 18, 2022
    Report Date
    June 5, 2022
    Manufacturer
    LUCIRA HEALTH, INC.
    Product Code
    QJR
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT WAS NOT RETURNED. THE ALLEGED ADDITIONAL FALSE POSITIVE REPORTED DATES BACK FROM (B)(6) 2022. THE CUSTOMER COULD NOT PROVIDE SPECIFIC INFORMATION ON DEVICE ASSOCIATION (DEVICE AND PACKAGING DISCARDED). THE CUSTOMER'S PURCHASING HISTORY WAS PULLED WHICH SHOWED TWO POSSIBLE KIT LOT NUMBERS THAT POTENTIALLY COULD BE ASSOCIATED. A DHR REVIEW OF THE TWO KIT LOT NUMBERS (K08A112112213M2/ K08A112203223M1) WERE 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 NOR ANY PREVIOUS COMPLAINTS FROM THIS CUSTOMER ASSOCIATED WITH "FALSE POSITIVE" RESULTS PRIOR. DHR REVIEW KIT LOT# K08A112112213M2: SAMPLE VIAL LOT DHR REVIEW: 2111125, 2111156, 2111049, 2111065 (ASSOCIATED INTERNAL LOT # 210762-2FO, 210762-2FT, 210762-2FE, 210762-2DT). TEST LOT DHRS REVIEW: 2112145, 2112156, 2112156, 2112156, 2112165, 2112192 (ASSOCIATED INTERNAL LOT # 210762-24U, 210762-24V, 210762-24W, 210762-24Y, 210762-25B, 210762-25F . 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). 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. ROOT CAUSE NOT YET AVAILABLE AT THIS TIME. FURTHER INVESTIGATION EFFORTS STILL IN-PROCESS. LUCIRA HEALTH IS IN THE PROCESS OF TESTING RETAINS OR INVENTORY STOCK ASSOCIATED WITH KIT LOT NUMBERS K08A112112213M2 AND K08A112203223M1 FOR FURTHER INVESTIGATIONAL INFORMATION. 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 (B)(6) 2022, THE CUSTOMER REPORTED 12 ALLEGED FALSE POSITIVES (8 OUT OF 12)) THAT DATED BACK FROM JANUARY 2022. TWO KIT LOT NUMBERS (K08A112112213M2/ K08A112203223M1) ASSOCIATED WITH THE CUSTOMERS PURCHASING HISTORY WERE INVESTIGATED. LUCIRA HEALTH, PULLED RETAINS ASSOCIATED WITH KIT LOT NUMBERS K08A112112213M2 ((B)(4) TEST UNITS, 30 SAMPLE VIALS) AND K08A112203223M1 ((B)(4) TEST UNITS, 50 SAMPLE VIALS) FOR FAILURE ANALYSIS (FA) TESTING. A FA INVESTIGATION WAS CONDUCTED ON MAY 18, 2022. THE TEST UNITS/SAMPLE VIALS WERE TESTED FOLLOWING WI162 (DEVICE LOT RELEASED-NO TEMPLATE CONTROL (NTC) TESTING) SECTION 9.3, TO DUPLICATE THE HIGH FALSE POSITIVE RATE REPORTED WITH THE RETAINED DEVICES. ALL RETAINED DEVICES PASSED WITHOUT ANY FALSE POSITIVE RESULTS. THEREFORE, LUCIRA HEALTH WAS UNABLE TO DUPLICATE THE HIGH RATE OF ALLEGED FALSE POSITIVES IN THE INTERNAL TESTING AND KIT LOT # K08A112112213M2 AND K08A112203223M1 BOTH 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): 11-TESTING OF DEVICE FROM SAME LOT/BATCH RETAINED BY MANUFACTURER 4110-TREND ANALYSIS

    Description of Event or Problem · 0

    ONE DEVICE REPORTED AS HAVING A FALSE POSITIVE RESULT. A PCR TEST OR AN ADDITIONAL LUCIRA TEST WAS PERFORMED WITH A NEGATIVE RESULT FOR CONFIRMATION FOLLOWING THE POSITIVE RESULT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1214959 CHECK-IT COVID-19 TEST QJR LUCIRA HEALTH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown