BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHECK-IT

    MDR report key: 14313688 · Received May 7, 2022

    Report

    Report Number
    3016521623-2022-00164
    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
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT HAS NOT BEEN RETURNED. A DHR REVIEW OF THE ASSOCIATED KIT LOT NUMBER (K08A112112213M2) 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 (B)(4) (LABEL CLAIM)/(B)(4) (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# 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 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 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 APRIL 18, 2022, THE CUSTOMER REPORTED 1 ALLEGED FALSE POSITIVE ASSOCIATED WITH KIT LOT NUMBER K08A112112213M2 (3016521623-2022-00164). LUCIRA HEALTH, PULLED RETAINS ASSOCIATED WITH KIT LOT NUMBER K08A112112213M2 (30 TEST UNITS, 30 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 FALSE POSITIVE REPORTED ASSOCIATED WITH KIT LOT NUMBER K08A112112213M2. ALL RETAINED DEVICES PASSED WITHOUT ANY FALSE POSITIVE RESULTS. THEREFORE, LUCIRA HEALTH WAS UNABLE TO DUPLICATE THE REPORTED ALLEGED FALSE POSITIVE IN THE INTERNAL TESTING AND KIT LOT # K08A112112213M2 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. THE COMPLAINANT PERFORMED AN ADDITIONAL LUCIRA TEST WITH CONFIRMATION OF A NEGATIVE RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1214888 CHECK-IT COVID-19 TEST KIT QJR LUCIRA HEALTH, INC. K08A112112213M2

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other