BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUCIRA CHECK-IT COVID-19 TEST

    MDR report key: 17430682 · Received July 31, 2023

    Report

    Report Number
    3016521623-2023-00476
    Event Type
    Malfunction
    Date Received
    July 31, 2023
    Date of Event
    July 16, 2023
    Report Date
    July 27, 2023
    Manufacturer
    PFIZER, INC.
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON INVESTIGATION OF THIS COMPLAINT, NO HARMS REPORTED. A DHR REVIEW CANNOT BE COMPLETED AS LOT INFORMATION WAS NOT PROVIDED. THE REVIEW OF TRENDING DATA FOR THE FAILURE MODE (FALSE POSITIVE) WAS COMPLETED. 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). PFIZER WILL CONTINUE TO MONITOR TRENDS RELATED TO FALSE POSITIVE RESULTS. 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 PFIZER 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. THIS DEVICE IS MARKETED UNDER EUA (B)(4) LUCIRA CHECK-IT COVID-19 TEST KIT.

    Description of Event or Problem · 0

    ONE DEVICE REPORTED AS HAVING ALLEGED FALSE POSITIVE RESULT. THE COMPLAINANT MENTIONED THE USER TOOK PCR TESTS AT LABCORP AND ANTIGEN TESTS WITH NEGATIVE RESULTS FOR CONFIRMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    874820 LUCIRA CHECK-IT COVID-19 TEST COVID-19 TEST KIT QJR PFIZER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other