BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHECK-IT

    MDR report key: 16464768 · Received March 1, 2023

    Report

    Report Number
    3016521623-2023-00100
    Event Type
    Malfunction
    Date Received
    March 1, 2023
    Date of Event
    February 14, 2023
    Report Date
    February 16, 2023
    Manufacturer
    LUCIRA HEALTH, INC.
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT HAS NOT BEEN RETURNED AND NO HARM(S) REPORTED. A DHR REVIEW OF THE ASSOCIATED KIT LOT NUMBER (K08A111712213M2) 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 NOR ANY PREVIOUS COMPLAINTS FROM THIS CUSTOMER ASSOCIATED WITH "FALSE POSITIVE" RESULTS PRIOR TO RECEIVED DATE OF (B)(6) 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. 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. SAMPLE VIAL LOT DHR REVIEW: 2112170, 2112041, 2112042, 2111049, 2112076 (ASSOCIATED INTERNAL LOT #210762-2JY, 210762-2IV, 210762-2IW, 210762-2FE, 210762-2JT) TEST LOT DHRS REVIEW: 2112156, 2112047, 2112013, 2112047, 2112013, 2112021, 2112021, 2112021, 2112021, 2112021, 2112067 (ASSOCIATED INTERNAL LOT #210762-24V, 210762-21R, 210762-21U, 210762-21V, 210762-21W, 210762-21X, 210762-21Z, 10762-22A, 210762-22B, 210762-22C, 210762-22E) BASED ON THE LIMITED INFORMATION AVAILABLE, ROOT CAUSE CANNOT BE DETERMINED. WITH ANY POTENTIAL FALSE POSITIVE RESULT, THERE ARE SEVERAL POTENTIAL ROOT CAUSES: LOW VIRAL LOAD IN PATIENT SAMPLE THAT IS BELOW THE LOD OF THE LUCIRA AND REFERENCE TEST. AT VIRAL LOADS CLOSE TO LOD A TEST DETECTS A POSITIVE >95% OF THE TIME. WHEN THE VIRAL LOAD IS BELOW LOD, THE FOLLOW-UP TEST CANNOT PICK UP POSITIVE RELIABLY AND CAN GENERATE THE IMPRESSION OF A FALSE POSITIVE RESULT. LOW VIRAL LOADS CAN ALSO RESULT IN SAMPLING VARIABILITY BETWEEN SAMPLES. ENVIRONMENTAL CONTAMINATION FROM OTHER POSITIVES BEING TESTED IN THAT ENVIRONMENT OR DUE TO IMPROPER COLLECTION OR HANDLING OF THE SPECIMEN. DEVICE MALFUNCTION - PLEASE NOTE OUR DEVICES ARE EXTENSIVELY INSPECTED AND TESTED THROUGH A ROBUST LOT RELEASE PROCESS AND THIS SCENARIO IS HIGHLY UNLIKELY. 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 ALLEGED FALSE POSITIVE RESULT. THE COMPLAINANT TOOK TWO ADDITIONAL ANTIGEN TESTS WITH NEGATIVE RESULTS FOR CONFIRMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    453301 CHECK-IT COVID-19 TEST KIT QJR LUCIRA HEALTH, INC. K08A111712213M2

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other