BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHECK-IT

    MDR report key: 15353418 · Received September 2, 2022

    Report

    Report Number
    3016521623-2022-00324
    Event Type
    Malfunction
    Date Received
    September 2, 2022
    Date of Event
    August 25, 2022
    Report Date
    September 2, 2022
    Manufacturer
    LUCIRA HEALTH, INC.
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT HAS NOT BEEN RETURNED AND NO HARM(S) REPORTED. THEREFORE, A DHR REVIEW WAS COMPLETED FOR KIT LOT NUMBER K08A111102224M1 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 THESE LOTS. KIT LOT NUMBER K08A111102224M1, HAS 1 SIMILAR COMPLAINT (B)(4) WITH A TOTAL OF EIGHTY-ONE ALLEGED FALSE POSITIVES REPORTED. THERE WERE EIGHTY-ONE ALLEGED FALSE POSITIVES REPORTED FROM A DIFFERENT CUSTOMER ASSOCIATED WITH K08A111104224M1. A FAILURE ANALYSIS (FA) WAS CONDUCTED FOR KIT LOT # K08A111104224M1 ON MARCH 02, 2022, ASSOCIATED WITH COMPLAINT (B)(4). THE DEVICES (B)(4) WERE TESTED FOLLOWING WI162 (DEVICE LOT RELEASED-NO TEMPLATE CONTROL (NTC) TESTING) SECTION 9.3, TO DUPLICATE THE HIGH FALSE POSITIVE RATE REPORTED WITH THE RETURNED DEVICES. ALL RETURNED DEVICES PASSED WITHOUT ANY FALSE POSITIVE RESULTS. THEREFORE, LUCIRA HEALTH WAS UNABLE TO DUPLICATE THE HIGH RATE OF FALSE POSITIVES IN THE INTERNAL TESTING AND KIT LOT # K08A111102224M1 STILL PASSED THE RELEASE CRITERIA. COMPLAINT WAS NOT CONFIRMED. 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. (B)(4). DHR REVIEW KIT LOT# K08A111104224M1: TEST LOT DHRS REVIEWED: 2202016, 2202015, 2202013, 2202014 (ASSOCIATED INTERNAL LOT # 220008-16X, 220008-16T, 220008-16N, 220008-16M, 220008-16R, 220008-16O, 220008-16Q, 220008-16W, 220008-16U, 220008-16V). SAMPLE VIAL LOT DHRS REVIEWED: 2201252, 2201333, 2201155, 2201251, 2201214, 2201332, 2201213 (ASSOCIATED INTERNAL LOT #S 220008-2R, 220008-5B, 220008-2H, 220008-2Q, 220008-2K, 220008-5A, 220008-2J). 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. 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) CHECK-IT. EXPIRATION DATE OF KIT LOT NUMBER K08A111102224M1-01/12/2023.

    Description of Event or Problem · 0

    ONE DEVICE REPORTED AS HAVING AN ALLEGED FALSE POSITIVE RESULT. THE COMPLAINANT MENTIONED AN INDIVIDUAL TESTED POSITIVE WITH A LUCIRA TEST (KIT LOT NUMBER: K08A111102224M1) AND RETESTED WITH A PCR TEST RECEIVING A NEGATIVE RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    417603 CHECK-IT COVID-19 TEST KIT QJR LUCIRA HEALTH, INC. K08A111102224M1

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other