BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHECK-IT

    MDR report key: 13458237 · Received February 4, 2022

    Report

    Report Number
    3016521623-2022-00020
    Event Type
    Malfunction
    Date Received
    February 4, 2022
    Date of Event
    January 16, 2022
    Report Date
    January 31, 2022
    Manufacturer
    LUCIRA HEALTH, INC.
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    PHYSICIAN ASSISTANT
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT WAS NOT RETURNED. A DHR REVIEW OF THE ASSOCIATED KIT LOT NUMBER (K08A110401224M1) WERE COMPLETED, AND 0 DISCREPANCIES WERE FOUND. 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. SAMPLE VIAL LOT DHRS REVIEWED: 2112320, 2112296 (ASSOCIATED INTERNAL LOT #S 211346.1-1Q AND 211346.1-1L) TEST LOT DHRS REVIEWED: 2112080, 2112364, 2111061, 2112300, 2112232, 2112349, 2112078 (ASSOCIATED INTERNAL LOT #S 210762-23Z, 2113462-3G, 210762-13W, 211346.2-1O, 210762-26K, 2113462-2W, 2113462-2V, 210762-23K) 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. THIS DEVICE IS MANUFACTURED UNDER (B)(4) CHECK-IT.

    Description of Event or Problem · 0

    ONE DEVICE REPORTED AS HAVING A FALSE POSITIVE RESULT. COMPLAINANT PERFORMED AN ADDITIONAL QUICKVUE TEST AND TWO PCR TESTS WITH NEGATIVE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1337307 CHECK-IT COVID-19 TEST KIT QJR LUCIRA HEALTH, INC. K08A110401224M1

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other