BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHECK-IT

    MDR report key: 16172846 · Received January 16, 2023

    Report

    Report Number
    3016521623-2023-00010
    Event Type
    Malfunction
    Date Received
    January 16, 2023
    Date of Event
    January 1, 2023
    Report Date
    January 6, 2023
    Manufacturer
    LUCIRA HEALTH, INC.
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT HAS NOT BEEN RETURNED. THEREFORE, A DHR REVIEW WAS COMPLETED FOR KIT LOT NUMBER K07A110601224M1. THERE IS 1 SIMILAR COMPLAINT (B)(4) WITH REPORT OF AN ALLEGED FALSE POSITIVE DEVICE ASSOCIATED WITH KIT LOT NUMBER K07A110601224M1 FROM DIFFERENT COMPLAINANT. AN INVESTIGATION INTO THESE SIMILAR COMPLAINTS HAVE BEEN COMPLETED TO OBTAIN ADDITIONAL INFORMATION. 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). KIT LOT# K07A110601224M1 DHR REVIEW REFERENCE: SAMPLE VIAL LOT DHR REVIEW: 2112059, 2112150, 2112166, 2112167, 2112189, 2112199, 2112229, 2112293, 2112259, 2112294, 2112260, 2112261, 2112317, 2112318, 2112058 (ASSOCIATED INTERNAL LOT # 211087-3H, 211087-3N, 211087-3P, 211087-3Q , 211087-3T, 211087-2W, 211087-2Y, 211087-4O, 211087-4B, 211087-4C, 211087-4G, 211087-4H, 211087-4M, 211087-4N, 211087-3G). TEST LOT DHRS REVIEW: 2112128, 2112128, 2112158, 2112174, 2112174, 2112174, 2112192, 2112192, 2112210, 2112212, 2112248, 2112302, 2112327, 2112356, 2112405, 2112047, 2112047, 2112107, 2112107 (ASSOCIATED INTERNAL LOT 211275-2C, 211275-2D, 211275-2E, 211275-2F, 211275-2H, 211275-2J, 211275-2L, 211275-2N, 211275-2O, 211275-2Q, 211275-2S, 211275-2X, 2114921-1A, 2114921-1I, 2114921-1N, 211275-1W, 211275-1X, 211275-2A, 211275-2B) BASED ON THE LIMITED INFORMATION AVAILABLE, ROOT CAUSE CANNOT BE DETERMINED. WITH ANY POTENTIAL FALSE POSITIVE RESULT, THERE ARE SEVERAL POTENTIAL ROOT CAUSES: LOW VIRAL LOAD IN PATIENT SAMPLE THAT IS BELOW THE LOD OF THE LUCIRA AND REFERENCE TEST. AT VIRAL LOADS CLOSE TO LOD A TEST DETECTS A POSITIVE >95% OF THE TIME. WHEN THE VIRAL LOAD IS BELOW LOD, THE FOLLOW-UP TEST CANNOT PICK UP POSITIVE RELIABLY AND CAN GENERATE THE IMPRESSION OF A FALSE POSITIVE RESULT. LOW VIRAL LOADS CAN ALSO RESULT IN SAMPLING VARIABILITY BETWEEN SAMPLES. ENVIRONMENTAL CONTAMINATION FROM OTHER POSITIVES BEING TESTED IN THAT ENVIRONMENT OR DUE TO IMPROPER COLLECTION OR HANDLING OF THE SPECIMEN. DEVICE MALFUNCTION - PLEASE NOTE OUR DEVICES ARE EXTENSIVELY INSPECTED AND TESTED THROUGH A ROBUST LOT RELEASE PROCESS AND THIS SCENARIO IS HIGHLY UNLIKELY. 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 AN ALLEGED FALSE POSITIVE RESULT. THE COMPLAINANT TOOK MULTIPLE ANTIGEN TEST PRIOR TO PERFORMING THE LUCIRA TEST AND RECEIVED NEGATIVE RESULTS. THE COMPLAINANT PERFORMED A LUCIRA TEST WITH A POSITIVE RESULT. FOR CONFIRMATION, THE COMPLAINANT TOOK AN ADDITIONAL LUCIRA TEST AND A PCR LAB TEST BOTH WITH NEGATIVE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    819079 CHECK-IT COVID-19 TEST KIT QJR LUCIRA HEALTH, INC. K07A110601224M1

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other