BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHECK-IT

    MDR report key: 15294097 · Received August 25, 2022

    Report

    Report Number
    3016521623-2022-00297
    Event Type
    Malfunction
    Date Received
    August 25, 2022
    Date of Event
    August 11, 2022
    Report Date
    August 18, 2022
    Manufacturer
    LUCIRA HEALTH, INC.
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT HAS NOT BEEN RETURNED. THE REVIEW OF TRENDING DATA FOR THE FAILURE MODE (FALSE POSITIVE) WAS COMPLETED. THERE IS 1 ADDITIONAL COMPLAINT FROM THIS CUSTOMER (B)(4) ASSOCIATED WITH REPORT OF MORE THAN ONE ALLEGED "FALSE POSITIVE" RESULT WITH NO DEVICE INFORMATION PROVIDED. FOR COMPLAINT (B)(4), THE CUSTOMER PROVIDED INFORMATION PERTAINING TO ONE KIT LOT NUMBER (K08A110703223M1) REPORTED TO BE ASSOCIATED WITH THE LUCIRA TESTS PERFORMED. THERE WERE ELEVEN LUCIRA TESTS PERFORMED IN TOTAL, SEVEN DEVICES REPORTED AS HAVING ALLEGED FALSE POSITIVE RESULTS AND FOUR DEVICES WITH NEGATIVE RESULTS. IT IS UNKNOWN, IF THE PROVIDED KIT LOT NUMBER IS ASSOCIATED WITH ANY OF THE DEVICES REPORTED AS HAVING AN ALLEGED FALSE POSITIVE RESULT. THERE ARE NO EXISTING CAPA, SCAR, OR NCMR RECORDS RELATED TO "FALSE POSITIVE" FAILURE MODE FOR THE REPORTED LOT (K08A110703223M1). HOWEVER, A DHR REVIEW WAS CONDUCTED FOR KIT LOT NUMBER K08A110703223M1 AS PART OF THE INVESTIGATION. THERE WERE 0 DISCREPANCIES FOUND (ALL LOTS PASSED IN TOTAL PER THE SAMPLING PLAN). DHR REVIEW FOR KIT LOT NUMBER K08A110703223M1: SAMPLE VIAL LOT DHR REVIEW: 2202439 (ASSOCIATED INTERNAL LOT # 220124-4E). TEST LOT DHRS REVIEW: 2202398, 2202396, 2202384, 2202395 (ASSOCIATED INTERNAL LOT # 220124-24R, 220124-24P, 220124-24I, 220124-24J). 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). ACCORDING TO THE FAILURE RATE (0.11%) FOR KIT LOT NUMBER K08A110703223M1, THE NUMBER OF FALSE POSITIVES (7 ALLEGED FALSE POSITIVES REPORTED FROM KIT LOT K08A110703223M1) IN RELATION TO THE TOTAL LOT QUANTITY PRODUCED (15,500) IS UNDER THE EXPECTED THRESHOLDS REFERENCED ABOVE (LABEL CLAIM AND INTERNAL WARNING LIMIT). BASED ON THE LIMITED INFORMATION AVAILABLE, ROOT CAUSE CANNOT BE DETERMINED. LUCIRA HEALTH WILL CONTINUE TO MONITOR TRENDS RELATED TO FALSE POSITIVE RESULTS IN ACCORDANCE WITH POST-MARKET SURVEILLANCE PROCESS. 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 REPORT. THE COMPLAINANT REPORTED PERFORMING TWO LUCIRA TESTS, THE FIRST TEST RESULTED IN A POSITIVE RESULT AND THE 2ND TEST RESULTED IN A NEGATIVE RESULT. THE CUSTOMER FOLLOWED UP WITH A SERIES OF ANTIGEN TESTS (8) AND A PCR TEST WITH NEGATIVE RESULTS FOR CONFIRMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2319039 CHECK-IT COVID-19 TEST KIT QJR LUCIRA HEALTH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other