BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHECK-IT

    MDR report key: 15396777 · Received September 9, 2022

    Report

    Report Number
    3016521623-2022-00411
    Event Type
    Malfunction
    Date Received
    September 9, 2022
    Date of Event
    September 1, 2022
    Report Date
    September 9, 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 K08A112203224M1 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 K08A112203224M1, HAS 0 ADDITIONAL COMPLAINTS FROM THIS CUSTOMER NOR ANY OTHER CUSTOMER ASSOCIATED WITH A "FALSE POSITIVE" FAILURE MODE PRIOR TO THE REPORTED RECEIPT 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 2% (LABEL CLAIM)/1% (INTERNAL WARNING LIMIT). ACCORDING TO THE FAILURE RATE (0.002%) FOR THIS LOT, THE NUMBER OF FALSE POSITIVES (1-TOTAL ALLEGED FALSE POSITIVE DEVICES REPORTED FROM LOT) IN RELATION TO THE TOTAL LOT QUANTITY PRODUCED (41,000) IS UNDER THE EXPECTED THRESHOLD. KIT LOT# K08A112203224M1 DHR REVIEW REFERENCE: SAMPLE VIAL LOT DHR REVIEW: 2202500, 2202462, 2203190, 2203101, 2203231 (ASSOCIATED INTERNAL LOT # 220124-1Z, 220124-4F, 220124-4J, 220124-4U, 220124-7L) TEST LOT DHRS REVIEW: 2203095, 2203143, 2203194, 2203193, 2203192, 2203195, 2203195, 2203193, 2203192, 2203198, 2203280, 2203283, 2203283, 2203283 (ASSOCIATED INTERNAL LOT # 220305-3O, 220305-6S, 220305-9H, 220305-6Z, 220305-6W, 220305-9C, 220305-9D, 220305-9A, 220305-6Y, 220305-9O, 220305-12S, 220305-15C, 220305-15D, 220305-15B). 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 (B)(4) CHECK-IT. EXPIRATION DATE OF KIT LOT NUMBER K08A112203224M1-02/09/2023.

    Description of Event or Problem · 0

    ONE DEVICE REPORTED AS HAVING AN ALLEGED FALSE POSITIVE RESULT. THE COMPLAINTANT REPORTED THAT AN INDIVIDUAL PERFORMED A LUCIRA TEST (KIT LOT NUMBER K08A112203224M1) WITH A POSTITIVE RESULT. THE CUSTOMER RETESTED WITH AN ACCULA (PCR) TEST WITH A NEGATIVE RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2215916 CHECK-IT COVID-19 TEST KIT QJR LUCIRA HEALTH, INC. K08A112203224M1

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other