BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALL-IN-ONE

    MDR report key: 13671101 · Received March 4, 2022

    Report

    Report Number
    3016521623-2022-00046
    Event Type
    Malfunction
    Date Received
    March 4, 2022
    Date of Event
    February 7, 2022
    Report Date
    March 2, 2022
    Manufacturer
    LUCIRA HEALTH, INC.
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED. A REVIEW OF THE TRENDING DATA FOR THE FAILURE MODE "FALSE POSITIVE" WAS COMPLETED. THERE ARE 2 ADDITIONAL COMPLAINTS FROM THIS CUSTOMER ((B)(4)) THAT ARE NOT ASSOCIATED WITH A "FALSE POSITIVE" FAILURE MODE AND ARE NOT RELATED TO THE REPORTED KIT LOT NUMBER (K07A04200121101). THERE HAS BEEN NO PREVIOUS FAILURE ANALYSIS (FAS) CONDUCTED ON THIS LOT NUMBER FOR FAILURE MODE "FALSE POSITIVE". THEREFORE, A DHR REVIEW HAS BEEN PERFORMED AS PART OF THE INVESTIGATION. SAMPLE VIAL LOT DHR REVIEW: 2101011 (ASSOCIATED INTERNAL LOT #S 2012095). TEST LOT DHRS REVIEW: 2106146, 2106145, 2106114 (ASSOCIATED INTERNAL LOT # 210348-4L, 210348-4K, 210348-4G). A REVIEW OF EXISTING CAPAS, SCARS AND NCRS WERE COMPLETED AND THERE IS 1 NCR ((B)(4)) RECORD ASSOCIATED WITH VIAL LOT NUMBER 2012095 (VIAL004)/ DEVICE MODULE LOT 200819-4U. DETAILS: THE VIAL004 WAS CRACKED IN THE DEVICE THAT HAD A GROSS LEAK. DEVICE LOT RELEASE OF 200819-4U WAS RELEASED DUE TO PASSING ALL LOT RELEASE ACCEPTANCE CRITERIA AND THE GROSS LEAK CAUSED BY THE SPT WENT THROUGH FURTHER INVESTIGATION. INVESTIGATION OUTCOME: THE DEVICE MODULE LOT 200819-4U WAS RELEASED DUE TO THE FAILURE OF A GROSS LEAK NOT ATTRIBUTED TO THE DEVICES AND PASSED ALL LOT RELEASE ACCEPTANCE CRITERIA. CONTAINMENT STUDY AT AN AQL OF 0.15 SIMILAR TO GROSS LEAK AQL PER WI162 WAS PERFORMED ON THE CRACKED SPT LOT TO DETERMINE IF IT WAS A REPETITIVE ISSUE. QUALITY ENGINEERING INSPECTED 189 SPTS FROM LOT 2012095 AND DID NOT OBSERVE ANY MORE FAILURES. SPT LOT 2012095 WAS DISPOSITIONED TO BE RELEASED. SUMMARY: THE REPORTED DEVICE WAS NOT RETURNED FOR A FAILURE ANALYSIS (FA) TO BE CONDUCTED AND THE 1 IDENTIFIED (B)(4) RELATED TO A CRACKED VIAL WHICH RESULTED IN A GROSS LEAK WAS IDENTIFIED NOT TO BE A REPETITIVE ISSUE. THE VIAL LOT 2012095 WAS RELEASED AFTER PASSING INSPECTION WITH NO FAILURES IDENTIFIED. THERE HAVE BEEN NO PREVIOUS COMPLAINTS FROM THIS CUSTOMER ASSOCIATED WITH FALSE POSITIVE RESULTS. 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 COMPLAINT REVIEW, NO HARM WAS REPORTED WITHIN THE COMPLAINT. THIS DEVICE IS MARKETED UNDER EUA (B)(4) ALL-IN-ONE.

    Description of Event or Problem · 0

    ONE DEVICE REPORTED AS HAVING A FALSE POSITIVE RESULT. COMPLAINANT REPORTED THAT A LABORATORY SITE PERFORMED A TEST WITH THE STERILE SWAB IN THE KIT (ALONE - WITHOUT BIOLOGICAL MATERIAL OR QC) AND THE TEST TURNED POSITIVE. IT WAS MENTIONED THAT THE SPACE WAS PROPERLY CLEANED PRIOR, AND THE TEST KIT WAS HANDLED PROPERLY. THE COMPLAINANT WAS PROVIDED INFORMATION PER LUCIRA'S IFU (QUALITY CONTROL TESTING FOR POINT OF CARE SETTINGS) AS SUGGESTED TO PERFORM THE CONTROL AGAIN PER THE INSTRUCTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2570042 ALL-IN-ONE COVID-19 TEST KIT QJR LUCIRA HEALTH, INC. K07A04200121101

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other