BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIAZYME DZ-LITE SARS-COV-2 IGG CLIA KIT

    MDR report key: 11566260 · Received March 24, 2021

    Report

    Report Number
    2032900-2021-00001
    Event Type
    Malfunction
    Date Received
    March 24, 2021
    Date of Event
    July 2, 2020
    Report Date
    March 24, 2021
    Manufacturer
    DIAZYME LABORATORIES INC.
    Product Code
    QKO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION HAS BEEN COMPLETED. RETAINED TESTING WITH LOT 2722000801 IGG REAGENT SHOWED PERFORMANCE WAS TO SPEC WITH CONTROLS AND PANEL SAMPLES. RISK WAS ASSESSED AS LOW BASED ON RETAINED TESTING PERFORMANCE TO SPEC, LOW INCIDENT REPORTED FOR LOT AND INTENDED USE IS NOT FOR DIAGNOSTIC USE. THE CONCLUSION IS LIKELY RELATED TO ANALYZER ISSUES, INDICATED IN INITIAL FEEDBACK. MULTIPLE CALIBRATIONS WERE PERFORMED, SUGGESTING POTENTIAL INSTRUMENT ISSUE. CANNOT CONFIRM ROOT CAUSE ERROR BECAUSE THE SAMPLE IN QUESTION WAS NOT AVAILABLE TO RETEST.

    Description of Event or Problem · 1

    CUSTOMER EXPRESSED CONCERN THAT DURING A STUDY A SAMPLE TESTED POSITIVE FOR COVID IGG ON THE ABBOTT ARCHITECT AND ON A LATERAL FLOW TEST. IT TESTED NEGATIVE ON THE DIAZYME IGG KIT. ON (B)(6) 2020, A REPRESENTATIVE FROM (B)(6) CONTACTED TECHNICAL SUPPORT, (B)(4), TO INFORM DIAZYME OF A POTENTIAL FALSE POSITIVE IGG RESULT. THE CUSTOMER (B)(6) INDICATED THAT THE INSTRUMENT WAS MOVED AND UPON RE-INSTALLATION, AND NOTED SOME FOUNTAINING AT THE PIPETTE TIP WASH STATION ALONG WITH A SLIGHT BOW IN THE TIP. THE ENGINEER CORRECTED THAT ISSUE AND REALIGNED THE TIPS. THE SYSTEM TEST POST-MOVE WAS IN SPEC AS WERE THE CALIBRATIONS AND QC. THE SAMPLE IN QUESTION HAD BEEN DISCARDED BY THAT TIME, IT WAS NOT AVAILABLE FOR RE-TESTING. GUIDANCE PROVIDED TO REFER TO IFU AND FDA WEBSITE: EUA AUTHORIZED SEROLOGY TEST PERFORMANCE FOR PPA/NPA AND PPV/NPV. THIS MDR 30 DAY REPORT IS LATE BECAUSE OF CONFUSION ABOUT RE PORTABILITY OF ALL ALLEGED FALSE RESULT FOR AN EUA DEVICE. WE HAVE BEEN IN COMMUNICATION WITH AND PROVIDED AI TO (B)(4) WHO WAS FOLLOWING UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463831 DIAZYME DZ-LITE SARS-COV-2 IGG CLIA KIT SARS-COV-2 IGG QKO DIAZYME LABORATORIES INC. 130219015M 2722000801

    Patients

    Seq Age Sex Outcome Treatment
    1