BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHECK-IT

    MDR report key: 15385187 · Received September 8, 2022

    Report

    Report Number
    3016521623-2022-00402
    Event Type
    Malfunction
    Date Received
    September 8, 2022
    Date of Event
    August 30, 2022
    Report Date
    September 7, 2022
    Manufacturer
    LUCIRA HEALTH, INC.
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT HAS NOT BEEN RETURNED AND NO HARM(S) REPORTED. THEREFORE, A DHR REVIEW WAS COMPLETED FOR KIT LOT NUMBER K08A110804223M2 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. KIT LOT NUMBER K08A110804223M2, HAS TWO SIMILAR COMPLAINTS (CP4953/ (B)(4) DIFFERENT CUSTOMER (4) AND CP5074/(B)(4) SAME CUSTOMER (5) WITH ALLEGED FALSE POSITIVES REPORTED ASSOCIATED WITH KIT LOT NUMBER K08A110804223M2. AN INVESTIGATION INTO THESE SIMILAR COMPLAINTS HAVE BEEN COMPLETED 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. (B)(4). ACCORDING TO THE FAILURE RATE (0.03%) FOR THIS LOT, THE NUMBER OF FALSE POSITIVES (16-TOTAL FALSE POSITIVE DEVICES REPORTED FROM SAME LOT) IN RELATION TO THE TOTAL LOT QUANTITY PRODUCED (63,065) IS UNDER THE EXPECTED THRESHOLD. DHR REVIEW KIT LOT# K08A110804223M2: SAMPLE VIAL LOT DHR REVIEW: 2202284, 2202439, 2203407, 2203138, 2203139, 2203158, 2203162, 2203222, 2203302, 2203362, 2203303 (ASSOCIATED INTERNAL LOT # 220124-1I, 220124-4E, 220124-4X, 220124-4V, 220124-4W, 220124-4P, 220124-7A, 220124-7E, 220124-7P, 220124-7X, 220124-7W) TEST LOT DHRS REVIEW: 2203616, 2203243, 2203243, 2203243, 2203245, 2203245, 2203245, 2203246, 2203305, 2203304, 2203304, 2203351, 2203351, 2203352, 2203352, 2203400, 2203351, 2203400, 2203401, 2203414 (ASSOCIATED INTERNAL LOT # 220305-30W, 220305-12C, 220305-12B, 220305-12A, 220305-12H, 220305-12G, 220305-12I, 220305-12K, 220305-15I, 220305-15E, 220305-15G, 220305-15W, 220305-15U, 220305-, 5Z, 220305-15Y, 220305-15S, 220305-15V, 220305-18L, 220305-18M, 220305-18R 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. 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 EUA (B)(4) CHECK-IT. EXPIRATION DATE OF KIT LOT NUMBER K08A110804223M2-02/03/2023.

    Description of Event or Problem · 0

    ONE DEVICE REPORTED AS HAVING AN ALLEGED FALSE POSITIVE RESULT. THE COMPLAINANT REPORTED THAT AN INDIVIDUAL PERFORMED A LUCIRA TEST (KIT LOT NUMBER K08A110804223M2) WITH A POSITIVE RESULT. THE CUSTOMER RETESTED WITH AN ACCULA (PCR) TEST WITH A NEGATIVE RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320066 CHECK-IT COVID-19 TEST KIT QJR LUCIRA HEALTH, INC. K08A110804223M2

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other