BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHECK-IT

    MDR report key: 16219696 · Received January 20, 2023

    Report

    Report Number
    3016521623-2023-00015
    Event Type
    Malfunction
    Date Received
    January 20, 2023
    Date of Event
    January 13, 2023
    Report Date
    January 17, 2023
    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. THEREFORE, A DHR REVIEW WAS COMPLETED FOR KIT LOT NUMBER K08A110110224M1 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. THERE ARE 0 ADDITIONAL COMPLAINTS FROM THIS CUSTOMER, NOR ANY OTHER CUSTOMER ASSOCIATED WITH A "FALSE POSITIVE" FAILURE MODE PRIOR TO THE REPORTED RECEIPT DATE OF JAN 17TH, 2023. 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). KIT LOT# K08A110110224M1 DHR REVIEW REFERENCE: SAMPLE VIAL LOT DHR REVIEW: 2112357, 2112358, 2112378, 2112395, 2112396, 2112398, 2112411, AND 2112416. TEST LOT DHRS REVIEW: 2201186, 2201152, 2201171, 2201172, 2201177, 2201180, 2201182, 2201186, 2201192, 2201195, 2201196, 2201210, 2201211, 2201220, AND 2201223. 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 AN ALLEGED FALSE POSITIVE RESULT. THE COMPLAINANT TOOK MULTIPLE ANTIGEN TESTS AND A PCR PRIOR TO PERFORMING THE LUCIRA TEST AND RECEIVED NEGATIVE RESULTS. THE COMPLAINANT TESTED POSITIVE WITH A ONE YEAR OLD LUCIRA TEST THAT HAD BEEN EXPOSED TO EXTREME HEAT IN THE CAR IN THE UTAH DESERT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2006095 CHECK-IT COVID-19 TEST KIT QJR LUCIRA HEALTH, INC. K08A112601224M1

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other