BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALL-IN-ONE

    MDR report key: 15578239 · Received October 11, 2022

    Report

    Report Number
    3016521623-2022-00435
    Event Type
    Malfunction
    Date Received
    October 11, 2022
    Date of Event
    September 30, 2022
    Report Date
    October 7, 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

    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). LUCIRA HEALTH 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 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. THIS DEVICE IS MARKETED UNDER EUA 202920 ALL-IN-ONE.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED AN ALLEGED FALSE POSITIVE RESULT FROM A LUCIRA TEST ADMINISTERED AT THE PALO ALTO MEDICAL FOUNDATION (SUTTER HEALTH), WHICH WAS OBTAINED PRIOR TO A SCHEDULED TREADMILL TEST AT THAT FACILITY. THE SAME DAY (2 HOURS LATER), THE PATIENT PERFORMED AN ANTIGEN TEST AND TOOK A PCR TEST WITH NEGATIVE RESULTS. THE FOLLOWING DAY, THE PATIENT TOOK AN ADDITIONAL PCR TEST FOR CONFIRMATION WITH A NEGATIVE RESULT. NO LUCIRA KIT LOT NUMBER INFORMATION PROVIDED ASSOCIATED WITH THE REPORTED DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2702526 ALL-IN-ONE COVID-19 TEST KIT QJR LUCIRA HEALTH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other