BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHECK-IT

    MDR report key: 15415336 · Received September 13, 2022

    Report

    Report Number
    3016521623-2022-00415
    Event Type
    Malfunction
    Date Received
    September 13, 2022
    Date of Event
    August 30, 2022
    Report Date
    September 13, 2022
    Manufacturer
    LUCIRA HEALTH, INC.
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT HAS NOT BEEN RETURNED. THEREFORE, A DHR REVIEW WAS COMPLETED FOR KIT LOT NUMBER K08A112502223M1 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 NOR ANY OTHER CUSTOMERS ASSOCIATED WITH A "FALSE NEGATIVE" FAILURE MODE PRIOR TO THE REPORTED RECEIPT DATE OF AUGUST 30, 2022. THE COMPLAINT RATE FOR "FALSE NEGATIVES" IS UNDER THE EXPECTED THRESHOLD OF 8% (LABEL CLAIM)/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# K08A112502223M1 DHR REVIEW REFERENCE: SAMPLE VIAL LOT DHR REVIEW: 2202145, 2202179, 2202177, 2202144, 2202143, 2202178 (ASSOCIATED INTERNAL LOT # 220008-9A, 220008-9E, 220008-6Y, 220008-6Z, 220008-6X, 220008-9B) TEST LOT DHRS REVIEW: 2202295, 2202313, 2202185, 2202184, 2202292, 2202322, 2202289, 2202171, 2202171, 2202290, 2202313, 2202323, 2202172, 2206167, 2202322, 2202171, 2202322, 2202182, 2202182, 2202292, 2202181 (ASSOCIATED INTERNAL LOT # 220124-18D, 220124-18E, 220124-9R, 220124-6Y, 220124-15U, 220124-18J, 220124-15P, 220124-9B, 220124-9C, 220124-15Q, 220124-18F, 220124-18M, 220124-9K, 220124-9J, 220124-18K, 220124-9A, 220124-18L, 220124-6S, 220124-6T, 220124-15T, 220124-6O). ADDITIONAL COMPLAINT INFORMATION: THE COMPLAINANT REPORTED A BUFFER SOLUTION COLOR CHANGE FROM PURPLE TO YELLOW DURING THE PERFORMANCE OF THE FIRST LUCIRA TEST KIT WITH A NEGATIVE RESULT (AFTER SAMPLE SWAB COLLECTION). THIS ISSUE COULD POTENTIALLY BE RELATED TO A PH CHANGE, MICROBIAL GROWTH, AND/OR CONTAMINATION WHICH COULD BE A CONTRIBUTING FACTOR TO THE RESULT RECEIVED. HOWEVER, IT IS UNKNOWN WHAT CAUSED THE COLOR CHANGE OF THE BUFFER SOLUTION. LUCIRA HEALTH IS TRACKING VIAL COLOR DISCOLORATION PER LOT NUMBER AND FURTHER ACTION WILL BE TAKEN IF REQUIRED. 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. EXPIRATION DATE OF KIT LOT NUMBER K08A112502223M1-01/28/2023.

    Description of Event or Problem · 0

    ONE DEVICE REPORTED AS HAVING AN ALLEGED FALSE NEGATIVE RESULT. THE COMPLAINANT REPORTED PERFORMING A LUCIRA TEST KIT WITH A NEGATIVE RESULT. THE COMPLAINANT STATED THE CUSTOMER RETESTED WITH AN ADDITIONAL LUCIRA TEST KIT WITH A POSITIVE RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2364635 CHECK-IT COVID-19 TEST KIT QJR LUCIRA HEALTH, INC. K08A112502223M1

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other