BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHECK-IT

    MDR report key: 13981145 · Received April 1, 2022

    Report

    Report Number
    3016521623-2022-00141
    Event Type
    Malfunction
    Date Received
    April 1, 2022
    Date of Event
    March 23, 2022
    Report Date
    March 31, 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 POSITIVE" FAILURE MODE FOR THIS LOT. HOWEVER, THERE IS AN ADDITIONAL COMPLAINT FROM THIS CUSTOMER ASSOCIATED WITH AN ALLEGED "FALSE POSITIVE" BUT DIFFERENT KIT LOT#. 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. 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 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. BASED ON THE COMPLAINT REVIEW, NO HARM WAS REPORTED WITHIN THE COMPLAINT. 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 (B)(4) CHECK-IT.

    Description of Event or Problem · 0

    ONCE DEVICE REPORTED AS HAVING A FALSE POSITVE RESULT. THE COMPLAINANT REPORTED ON BEHALF OF A HOSPITAL (B)(6), A FALSE POSITIVE RESULT FROM A LUCIRA TEST KIT. THE HOSPITAL LOCATION PERFORMED RT-PCR TESTING FOR CONFIRMATION RESULTING IN A NEGATIVE RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1192025 CHECK-IT COVID-19 TEST KIT QJR LUCIRA HEALTH, INC. K07A113108214M1

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other