BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHECK-IT

    MDR report key: 14121434 · Received April 15, 2022

    Report

    Report Number
    3016521623-2022-00156
    Event Type
    Malfunction
    Date Received
    April 15, 2022
    Date of Event
    March 31, 2022
    Report Date
    April 11, 2022
    Manufacturer
    LUCIRA HEALTH, INC.
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT WAS NOT RETURNED. A DHR REVIEW OF THE ASSOCIATED KIT LOT# K07A113108214M1 WERE COMPLETED 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 NEGATIVE" FAILURE MODE FOR THIS LOT. THERE ARE 0 ADDITIONAL COMPLAINTS FROM THIS CUSTOMER ASSOCIATED WITH A "FALSE NEGATIVE" FAILURE MODE. BASED ON REVIEW OF THE PRODUCT'S FMEAS AND RISK ASSESSMENT DOCUMENTATION, FALSE NEGATIVE TEST RESULTS ARE A KNOWN POSSIBLE OUTCOME REGARDING THIS ISSUE UNDER EVALUATION, REFER TO FMEA-004. THE COMPLAINT RATE FOR FALSE NEGATIVES IS UNDER THE EXPECTED THRESHOLD OF (B)(4) (LABEL CLAIM)/ (B)(4) (INTERNAL WARNING LIMIT). LUCIRA HEALTH WILL CONTINUE TO MONITOR TRENDS RELATED TO "FALSE NEGATIVE" RESULTS IN ACCORDANCE WITH POST-MARKET SURVEILLANCE PROCESS. KIT LOT# K07A113108214M1 DHR REVIEW REFERENCE: TEST LOT DHRS REVIEWED: 2107097, 2107062 (ASSOCIATED INTERNAL LOT # 210348-4Z, 210348-4W) SAMPLE VIAL LOT DHRS REVIEWED: 2108202 (ASSOCIATED INTERNAL LOT #S 2108091, 2108092) BASED ON THE COMPLAINT REVIEW, NO HARM WAS REPORTED WITHIN THE COMPLAINT. BASED ON THE LIMITED INFORMATION AVAILABLE, ROOT CAUSE CANNOT BE DETERMINED. POTENTIAL ROOT CAUSES INCLUDE BUT ARE NOT LIMITED TO: ENVIRONMENTAL CONTAMINATION, LOW VIRAL LOAD, AND/OR DEVICE FAILURE A SUPPLEMENTAL REPORT WILL BE FILED IF ANY FURTHER INVESTIGATION AND/OR ADDITIONAL INFORMATION IS OBTAINED. THIS DEVICE IS MARKETED UNDER EUA (B)(4) CHECK-IT.

    Description of Event or Problem · 0

    ONE DEVICE REPORTED AS HAVING A FALSE NEGATIVE RESULT. THE COMPLAINANT REPORTED THE ALLEGED FALSE NEGATIVE PERFORMED BY A LUCIRA TEST IN THE (B)(6) MEDICAL CENTERS EMERGENCY ROOM. A PATIENT WAS TESTED IN THE (B)(6) EMERGENCY ROOM AFTER RECEIVING A NEGATIVE RESULT FROM THE LUCIRA TEST. THE PATIENT WAS GIVEN A PCR TEST DETECTING VARIANT BA2 WITH A POSITIVE RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2174258 CHECK-IT COVID-19 TEST KIT QJR LUCIRA HEALTH, INC. K07A113108214M1

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other