BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COVID-19 TEST KIT

    MDR report key: 15384990 · Received September 8, 2022

    Report

    Report Number
    3016521623-2022-00390
    Event Type
    Malfunction
    Date Received
    September 8, 2022
    Date of Event
    August 29, 2022
    Report Date
    September 7, 2022
    Manufacturer
    LUCIRA HEALTH, 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). LUCIRA HEALTH WILL CONTINUE TO MONITOR TRENDS RELATED TO FALSE POSITIVE RESULTS. BASED ON THE LIMITED INFORMATION AVAILABLE, ROOT CAUSE CANNOT BE DETERMINED. A SUPPLEMENTAL REPORT WILL BE FILED IF ANY FURTHER INVESTIGATION AND/OR ADDITIONAL INFORMATION IS OBTAINED. LUCIRA HEALTH DEVICES ARE MARKETED UNDER EUA 210196 CHECK-IT AND EUA 202920 ALL-IN-ONE. IT IS UNKNOWN OF THE BRAND ASSOCIATED WITH THIS REPORTED COMPLAINT.

    Description of Event or Problem · 0

    ONE DEVICE REPORTED AS HAVING AN ALLEGED FALSE POSITIVE RESULT SENT VIA SOCIAL MEDIA (TWITTER). THE COMPLAINANT DID NOT PROVIDE KIT LOT NUMBER INFORMATION ASSOCIATED WITH THE LUCIRA TEST KIT PERFORMED WITH AN ALLEGED FALSE POSITIVE RESULT. THE COMPLAINANT MENTIONED RETESTING WITH TWO NASAL TESTS (1 FLOW AND 1 MODMD), ONE SALIVA TEST (FLOW), ONE FLU A/B TEST (MODMD), AND MULTIPLE OTHER TESTS (BINAX NOW, ACCULA (PCR), INDICAID) ALL WITH NEGATIVE RESULTS. NO ADDITIONAL INFORMATION PROVIDED FROM THE COMPLAINANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234849 COVID-19 TEST KIT QJR LUCIRA HEALTH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other