BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHECK-IT

    MDR report key: 13981032 · Received April 1, 2022

    Report

    Report Number
    3016521623-2022-00138
    Event Type
    Malfunction
    Date Received
    April 1, 2022
    Date of Event
    March 15, 2022
    Report Date
    March 31, 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 HAS NOT BEEN RETURNED. A DHR REVIEW OF THE ASSOCIATED KIT LOT NUMBER (K08A110401223M1) 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 FROM THIS CUSTOMER. HOWEVER, TREND ANALYSIS SHOWED 1 ADDITIONAL SIMILAR COMPLAINT FROM A DIFFERENT CUSTOMER ASSOCIATED WITH THE KIT LOT NUMBER (K08A110401223M1) AND ALLEGED "FALSE POSITIVE" FAILURE MODE. SIMILAR COMPLAINT: (B)(4). DHR REVIEW REFERENCE: SAMPLE VIAL LOT DHR REVIEW: 2112201, 2112231, 2112286, 2112263, 2112264, 2112322, 2112323 (ASSOCIATED INTERNAL LOT # 210762-2KG, 210762-2KN, 211346.1-1A, 211346.1-1F, 211346.1-1G, 211346.1-1R, 211346.1-1S) TEST LOT DHRS REVIEW: 2112192, 2112192, 2112192, 2112245, 2112245, 2112248, 2112248, 2112191, 2112191, 2112191, 2112191, 2112191, 2112188, 2112188, 2112208, 2112209, 2112327 (ASSOCIATED INTERNAL LOT # 210762-25E,210762-25F, 210762-25G, 210762-26Y, 210762-27B, 210762-27H, 210762-27I, 210762-25O, 210762-25P, 210762-25Q, 210762-25R, 210762-25T, 210762-25X, 210762-25Y, 210762-26B, 210762-26H, 2113462-2M) 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. 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. BASED ON THE COMPLAINT REVIEW, NO HARM WAS REPORTED WITHIN THE COMPLAINT. THIS DEVICE IS MARKETED UNDER EUA 210196 CHECK-IT.

    Description of Event or Problem · 0

    ONE DEVICE REPORTED AS HAVING A FALSE POSITIVE RESULT. THE COMPLAINANT ACCIDENTALLY PUSHED THE VIAL DOWN ON THE LUCIRA TEST, BEGAN THE TEST, A SECOND BEFORE MIXING IN THE SAMPLE IN RECEIVED A POSITIVE RESULT. THE COMPLAINANT TOOK A PCR TEST SHORTLY THEREAFTER, WHICH RESULTED IN A NEGATIVE. AN ADDITIONAL LUCIRA TEST WAS TAKEN 24 HOURS LATER WITH A NEGATIVE RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1968561 CHECK-IT COVID-19 TEST KIT QJR LUCIRA HEALTH, INC. K08A110401223M1

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other