BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHECK-IT

    MDR report key: 14142300 · Received April 19, 2022

    Report

    Report Number
    3016521623-2022-00161
    Event Type
    Malfunction
    Date Received
    April 19, 2022
    Date of Event
    April 8, 2022
    Report Date
    April 27, 2022
    Manufacturer
    LUCIRA HEALTH, INC.
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT WAS RETURNED AND A FAILURE ANALYSIS (FA) INVESTIGATION WAS CONDUCTED ALONG WITH A DHR REVIEW. A DHR REVIEW OF THE ASSOCIATED KIT LOT NUMBER (K08A110601224M2) 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. (B)(4). LUCIRA HEALTH WILL CONTINUE TO MONITOR TRENDS RELATED TO FALSE POSITIVE RESULTS IN ACCORDANCE WITH POST-MARKET SURVEILLANCE PROCESS. DHR REVIEW KIT LOT# K08A110601224M2: SAMPLE VIAL LOT DHR REVIEW: 2112411, 2110038, 2112377 (ASSOCIATED INTERNAL LOT # 2113461-2E, 210762-2AI, 2113461-2N). TEST LOT DHRS REVIEW: 2110257, 2111061, 2111061 (ASSOCIATED INTERNAL LOT # 210762-11W, 210762-13W, 210762-12O). FA-1757 INVESTIGATION OUTCOME: WHEN THE DEVICE WAS RECEIVED THE SAMPLE VIAL (SV) AND THE OLD BATTERIES WERE STILL ATTACHED. WHEN NEW BATTERIES WERE INSERTED, THE DEVICE SHOWED A POSITIVE RESULT. THE DEVICE DATA WAS DOWNLOADED AND RETRIEVED WHICH SHOWED CHAMBERS 5 AND 6 NEGATIVE (COVID 2 AND 3) AND CHAMBER 4 (COVID 1) AS POSITIVE. THIS DATA SHOWS THAT THERE WAS NO HARDWARE MALFUNCTION. THEREFORE, THE DISPLAYED RESULT MATCHED THE ASSAY OUTCOMES. THE POTENTIAL FALSE POSITIVE CAN BE ATTRIBUTABLE TO ALREADY ESTABLISHED ROOT CAUSES: LOW VIRAL LOAD, ENVIRONMENTAL CONTAMINATION, OR ASSAY 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.

    Additional Manufacturer Narrative · 0

    PRODUCT WAS RETURNED AND A FAILURE ANALYSIS (FA) INVESTIGATION WAS CONDUCTED ALONG WITH A DHR REVIEW. A DHR REVIEW OF THE ASSOCIATED KIT LOT NUMBER (K08A110601224M2) 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 APRIL 08, 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# K08A110601224M2: SAMPLE VIAL LOT DHR REVIEW: 2112411, 2110038, 2112377 (ASSOCIATED INTERNAL LOT # 2113461-2E, 210762-2AI, 2113461-2N) ; TEST LOT DHRS REVIEW: 2110257, 2111061, 2111061 (ASSOCIATED INTERNAL LOT # 210762-11W, 210762-13W, 210762-12O) . FA-1757 INVESTIGATION OUTCOME: WHEN THE DEVICE WAS RECEIVED THE SAMPLE VIAL (SV) AND THE OLD BATTERIES WERE STILL ATTACHED. WHEN NEW BATTERIES WERE INSERTED, THE DEVICE SHOWED A POSITIVE RESULT. THE DEVICE DATA WAS DOWNLOADED AND RETRIEVED WHICH SHOWED CHAMBERS 5 AND 6 NEGATIVE (COVID 2 AND 3) AND CHAMBER 4 (COVID 1) AS POSITIVE. THIS DATA SHOWS THAT THERE WAS NO HARDWARE MALFUNCTION. THEREFORE, THE DISPLAYED RESULT MATCHED THE ASSAY OUTCOMES. THE POTENTIAL FALSE POSITIVE CAN BE ATTRIBUTABLE TO ALREADY ESTABLISHED ROOT CAUSES: LOW VIRAL LOAD, ENVIRONMENTAL CONTAMINATION, OR ASSAY 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 PERFORMED A RAPID TEST WITH A NEGATIVE RESULT FOLLOWING THE POSITIVE RESULT FROM THE LUCIRA TEST KIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    818738 CHECK-IT COVID-19 TEST KIT QJR LUCIRA HEALTH, INC. K08A110601224M2

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other