BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHECK-IT

    MDR report key: 14404029 · Received May 15, 2022

    Report

    Report Number
    3016521623-2022-00185
    Event Type
    Malfunction
    Date Received
    May 15, 2022
    Date of Event
    April 25, 2022
    Report Date
    May 13, 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. A DHR REVIEW OF THE ASSOCIATED KIT LOT NUMBER (K08A110802223M1) 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. THERE IS ONE PREVIOUS ALLEGED FALSE POSITIVE REPORTED FROM THIS CUSTOMER (3016521623-2022-00178) WITH LOT INFORMATION NOT PROVIDED. THEREFORE, IT IS UNKNOWN IF THE PREVIOUS REPORT FROM THIS CUSTOMER WAS ASSOCIATED WITH KIT LOT NUMBER K08A110802223M1. 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). LUCIRA HEALTH WILL CONTINUE TO MONITOR TRENDS RELATED TO FALSE POSITIVE RESULTS IN ACCORDANCE WITH POST-MARKET SURVEILLANCE PROCESS. DHR REVIEW KIT LOT# K08A110802223M1: SAMPLE VIAL LOT DHR REVIEW: 2202055, 2201096 ASSOCIATED INTERNAL LOT # 220008-3A, 2113461-4H, 20008-3H. TEST LOT DHRS REVIEW: 2201341, 2201342, 2112301, 2201341, 2201339, 2112120 ASSOCIATED INTERNAL LOT # 211346.2-1F, 211364.2-1U, 2113462-1T, 210762-23W, 210762-17W, 210762-24I. 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. 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 REPORTED AN INDIVIDUAL PERFORMED A LUCIRA TEST WITH A POSITIVE RESULT. THE INDIVIDUAL FOLLOWED-UP WITH TWO ADDITIONAL LUCIRA TESTS WITH NEGATIVE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2092468 CHECK-IT COVID-19 TEST KIT QJR LUCIRA HEALTH, INC. K08A110802223M1

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other