BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHECK-IT

    MDR report key: 15802696 · Received November 15, 2022

    Report

    Report Number
    3016521623-2022-00458
    Event Type
    Malfunction
    Date Received
    November 15, 2022
    Date of Event
    November 3, 2022
    Report Date
    November 16, 2022
    Manufacturer
    LUCIRA HEALTH, INC.
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    H10 CORRECTED INFORMATION: 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 IN ACCORDANCE WITH POST-MARKET SURVEILLANCE PROCESS.

    Additional Manufacturer Narrative · 0

    PRODUCT HAS NOT BEEN RETURNED. THEREFORE, A DHR REVIEW WAS COMPLETED FOR KIT LOT NUMBER K08A110110224M2 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 NOVEMBER 03, 2022. 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 NEGATIVE RESULTS IN ACCORDANCE WITH POST-MARKET SURVEILLANCE PROCESS. KIT LOT# K08A110110224M2 DHR REVIEW REFERENCE: SAMPLE VIAL LOT DHR REVIEW: 2112112 (ASSOCIATED INTERNAL LOT # 210762-2JQ) TEST LOT DHRS REVIEW: 2111267 (ASSOCIATED INTERNAL LOT # 210762-18E) 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. LUCIRA HEALTH DEVICES ARE MARKETED UNDER (B)(4). 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 POSITVE RESULT. THE COMPLAINANT RETESTED WITH TWO LUCIRA TESTS WITH NEGATIVE RESULTS. FOR ADDITIONAL CONFIRMATION, A PCR TEST WAS TAKEN WITH A NEGATIVE RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373919 CHECK-IT COVID-19 TEST KIT QJR LUCIRA HEALTH, INC. K08A110110224M2

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other