BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHECK-IT

    MDR report key: 16172848 · Received January 16, 2023

    Report

    Report Number
    3016521623-2023-00011
    Event Type
    Malfunction
    Date Received
    January 16, 2023
    Date of Event
    January 3, 2023
    Report Date
    January 6, 2023
    Manufacturer
    LUCIRA HEALTH, INC.
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCTS HAVE NOT BEEN RETURNED. THE REVIEW OF TRENDING DATA FOR THE FAILURE MODE (FALSE POSITIVE) WAS COMPLETED. THERE ARE 0 ADDITIONAL COMPLAINTS FROM THIS CUSTOMER ASSOCIATED WITH AN ALLEGED "FALSE POSITIVE" RESULT. FOR COMPLAINT (B)(4), THE CUSTOMER PROVIDED INFORMATION PERTAINING TO TWO KIT LOT NUMBERS (K08A111710223M7 AND K08A110310223M8). HOWEVER, IT IS UNKNOWN WHICH KIT LOT NUMBER IS ASSOCIATED WITH THE REPORTED ALLEGED FALSE POSITIVE RESULT. THERE ARE NO EXISTING CAPA, SCAR, OR NCMR RECORDS RELATED TO "FALSE POSITIVE" FAILURE MODE FOR KIT LOT NUMBERS K08A111710223M7 OR K08A110310223M8. A DHR REVIEW WAS CONDUCTED FOR KIT LOT NUMBER K08A111710223M7 AND K08A110310223M8 AS PART OF THE INVESTIGATION. THERE WERE 0 DISCREPANCIES FOUND (ALL LOTS PASSED IN TOTAL PER THE SAMPLING PLAN). DHR REVIEW FOR KIT LOT NUMBER K08A111710223M7: SAMPLE VIAL LOT DHR REVIEW: 2207109 (ASSOCIATED INTERNAL LOT # 220471-3T) TEST LOT DHRS REVIEW: 2204245 (ASSOCIATED INTERNAL LOT # 220305-45F) DHR REVIEW FOR KIT LOT NUMBER K08A110310223M8: SAMPLE VIAL LOT DHR REVIEW: 2206142 (ASSOCIATED INTERNAL LOT # 220471-3M) TEST LOT DHRS REVIEW: 2204124 (ASSOCIATED INTERNAL LOT # 220305-39O) 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). ACCORDING TO THE FAILURE RATE (0.02%) FOR KIT LOT NUMBER K08A111710223M7, THE NUMBER OF FALSE POSITIVES (1-ALLEGED FALSE POSITIVE DEVICE REPORTED FROM KIT LOT K08A111710223M7) IN RELATION TO THE TOTAL LOT QUANTITY PRODUCED (5,094) IS UNDER THE EXPECTED THRESHOLDS REFERENCED ABOVE (LABEL CLAIM AND INTERNAL WARNING LIMIT). ACCORDING TO THE FAILURE RATE (0.02%) FOR KIT LOT NUMBER K08A110310223M8, THE NUMBER OF FALSE POSITIVES (1-ALLEGED FALSE POSITIVE DEVICE REPORTED FROM KIT LOT K08A110310223M8) IN RELATION TO THE TOTAL LOT QUANTITY PRODUCED (B)(4) IS UNDER THE EXPECTED THRESHOLDS REFERENCED ABOVE (LABEL CLAIM AND INTERNAL WARNING LIMIT). 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 LUCIRA HEALTH WILL CONTINUE TO MONITOR TRENDS RELATED TO FALSE POSITIVE RESULTS IN ACCORDANCE WITH POST-MARKET SURVEILLANCE PROCESS. 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).

    Description of Event or Problem · 0

    ONE DEVICE REPORTED AS HAVING AN ALLEGED FALSE POSITIVE RESULT. THE COMPLAINANT STATED THE USER RETESTED WITH AN ADDITIONAL LUCIRA TEST AND PCR LAB TEST BOTH WITH NEGATIVE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    819081 CHECK-IT COVID-19 TEST KIT QJR LUCIRA HEALTH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other