BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHECK-IT

    MDR report key: 14283935 · Received May 4, 2022

    Report

    Report Number
    3016521623-2022-00163
    Event Type
    Malfunction
    Date Received
    May 4, 2022
    Date of Event
    April 15, 2022
    Report Date
    May 2, 2022
    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

    PRODUCT WAS RETURNED AND A FAILURE ANALYSIS (FA) INVESTIGATION WAS CONDUCTED ALONG WITH A DHR REVIEW. A DHR REVIEW OF THE ASSOCIATED KIT LOT NUMBER (K08A111403223M1) WAS COMPLETED, AND 0 DISCREPANCIES WERE 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 INVESTIGATIONS FOR THIS LOT. THERE ARE THREE PREVIOUS ALLEGED FALSE POSITIVES REPORTED FROM THIS CUSTOMER (CP2441- 3016521623-2022-00132, 3016521623-2022-00133, 3016521623-2022-00134) WITH LOT INFORMATION NOT PROVIDED. THEREFORE, IT IS UNKNOWN IF THE PREVIOUS REPORTS FROM THIS CUSTOMER WERE ASSOCIATED WITH KIT LOT # K08A111403223M1. 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. DHR REVIEW KIT LOT# K08A111403223M1: SAMPLE VIAL LOT DHR REVIEW: 2110078, 2110108, 2110133, 2110194, 2110227, 2110228, 2110244, 2110266, 2111044, 2111064, 2111063, 2111062, 2111184 (ASSOCIATED INTERNAL LOT # 210762-2AZ, 210762-2BI, 210762-2BQ, 210762-2CL, 210762-2CS, 210762-2CT, 210762-2DA, 210762-2DF, 210762-2DI, 210762-2DS, 210762-2DR, 210762-2DK, 210762-2DU) TEST LOT DHRS REVIEW: 2110111, 2110171, 2110216, 2110229, 2201152, 2111022, 2111043, 2111039, 2111089, 2111118 (ASSOCIATED INTERNAL LOT # 210762-9N, 210762-10G, 210762-10W, 210762-11F, 220008-1X, 210762-12I, 210762-12J, 210762-12Y, 210762-13D, 210762-12R, 210762-13R, 210762-14W, 210762-14W) FA-1776 INVESTIGATION OUTCOME: WHEN DEVICE WAS RECEIVED ALL BUFFER LEAKED OUT AND OLD BATTERIES WERE STILL INSIDE. THE DEVICE DATA WAS DOWNLOADED AND RETRIEVED WHICH SHOWED A POSITIVE RESULT, BUT THE PIC CHAMBER READ INVALID RANGE. A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED. THE POTENTIAL FALSE POSITIVE CAN BE ATTRIBUTABLE TO ALREADY ESTABLISHED ROOT CAUSES: LOW VIRAL LOAD, ENVIRONMENTAL CONTAMINATION, OR DEVICE ISSUES. 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) CHECK-IT.

    Description of Event or Problem · 0

    ONE DEVICE REPORTED AS HAVING A FALSE POSITIVE RESULT. THE COMPLAINANT PERFORMED A DIAGNOSTIC SALIVA LAB PCR TEST (MIRIMUS LABS) WITH A NEGATIVE RESULT AFTER RECEIVING THE POSITIVE RESULT FROM THE LUCIRA TEST KIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1632448 CHECK-IT COVID-19 TEST KIT QJR LUCIRA HEALTH, INC. K08A111403223M1

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other