BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHECK-IT

    MDR report key: 14481682 · Received May 23, 2022

    Report

    Report Number
    3016521623-2022-00215
    Event Type
    Malfunction
    Date Received
    May 23, 2022
    Date of Event
    May 10, 2022
    Report Date
    May 20, 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 WAS NOT RETURNED. A DHR REVIEW OF THE ASSOCIATED KIT LOT# K08A111002224M4 WERE COMPLETED 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 NEGATIVE" FAILURE MODE FOR THIS LOT. THERE ARE 0 ADDITIONAL COMPLAINTS FROM THIS CUSTOMER ASSOCIATED WITH A "FALSE NEGATIVE" FAILURE MODE. BASED ON REVIEW OF THE PRODUCT'S FMEAS AND RISK ASSESSMENT DOCUMENTATION, FALSE NEGATIVE TEST RESULTS ARE A KNOWN POSSIBLE OUTCOME REGARDING THIS ISSUE UNDER EVALUATION, REFER TO FMEA-004. THE COMPLAINT RATE FOR FALSE NEGATIVES 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 NEGATIVE" RESULTS IN ACCORDANCE WITH POST-MARKET SURVEILLANCE PROCESS. KIT LOT# K08A111002224M4 DHR REVIEW REFERENCE: SAMPLE VIAL LOT DHR REVIEW: 2201253, 2201254, 2201337(ASSOCIATED INTERNAL LOT # 220008-3Q, 220008-3R, 220008-3T) TEST LOT DHRS REVIEW: 2202066, 2202065, 2202063, 2201315,2201316, 2201316, 2201315,2201331, 2201331,2 201331, 2201338, 2201338,2201338, 2201338, 2202014, 2202061 (ASSOCIATED INTERNAL LOT # 220124-3D, 220124-3B, 220124-3C, 220008-4L, 220008-4S, 220008-4M, 220008-4K, 220008-16H, 220008-16I, 220008-16J, 220008-16K,220008-16L, 220008-16M, 220008-16N, 220008-16R, 220008-20O) 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. BASED ON THE COMPLAINT REVIEW, NO HARM WAS REPORTED WITHIN THE COMPLAINT. A SUPPLEMENTAL REPORT WILL BE FILED IF ANY FURTHER INVESTIGATION AND/OR ADDITIONAL INFORMATION IS OBTAINED. THIS DEVICE IS MARKETED UNDER EUA (B)(4) CHECK-IT.

    Description of Event or Problem · 0

    ONE DEVICE REPORTED AS HAVING AN ALLEGED FALSE NEGATIVE RESULT. THE COMPLAINANT FIRST TOOK A PCR TEST IN A LAB WITH A POSITIVE RESULT, FOLLOWED BY A LUCIRA TEST WITH A NEGATIVE RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201150 CHECK-IT COVID-19 TEST KIT QJR LUCIRA HEALTH, INC. K08A111002224M4

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other