BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 2466414 · Received February 23, 2012

    Report

    Report Number
    2122870-2012-00469
    Event Type
    Malfunction
    Date Received
    February 23, 2012
    Date of Event
    January 9, 2012
    Report Date
    January 30, 2012
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLES WERE COLLECTED IN 16X100, BD VACUTAINER TUBES WITH GEL. THE SPECIMENS WERE CENTRIFUGED AT 3,500 RPM. THE SAMPLES WERE STORED AT ROOM TEMPERATURE AND APPROXIMATELY 5-6 HOURS OLD. SAMPLE TYPE WAS NOT SUPPLIED. A SYSTEM CHECK REPORT FROM (B)(6) 2012 INDICATES THAT ALL PORTIONS PASSED WITHIN PUBLISHED SPECIFICATIONS. AFTER REVIEW OF THE SUPPLIED DATA, IT SHOWS THE CUSTOMER IS ONLY RUNNING QC ONCE WEEKLY, AND PROVIDED QC DATA DOES NOT SHOW SIGNIFICANT DECREASE USING UE3 REAGENT LOT NUMBER 023251. THE CUSTOMER WAS ASKED TO FOLLOW-UP THE QC DAILY AND TO PERFORM A PRECISION STUDY WITH TWO LEVELS OF QC. OTHER LOTS OF UE3 REAGENT (023355, 017780 AND 114041) USED BY THE CUSTOMER WERE ALSO EXPERIENCING SIMILAR ISSUES. THERE IS NO INDICATION SERVICE WAS DISPATCHED FOR THIS EVENT. ROOT CAUSE OF THIS EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BEC) REGARDING LOWER THAN EXPECTED UNCONJUGATED ESTRIOL (UE3) RESULTS GENERATED BY THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM FOR AN UNSPECIFIED NUMBER OF PATIENTS. THE CUSTOMER INDICATED THAT DECREASING MEDIAN VALUES FOR UE3 WAS OBSERVED AS A PART OF THEIR TRISOMY SCREENING. THIS DECREASE IN MEDIANS FOR UE3 CAUSES MORE FALSE POSITIVE SCREENING RESULTS. THE CUSTOMER COMPARED (B)(6) 2011 RESULTS TO CURRENT, (B)(6) 2012, AND FOUND THE INITIAL POSITIVE SCREENING RATE IS HIGHER IN (B)(6) 2012. IT HAS BEEN REQUESTED THE CUSTOMER PROVIDE SPECIFIC DETAILS FOR THESE EVENTS. HOWEVER, NO PATIENT RESULTS OR ADDITIONAL INFORMATION WAS SUPPLIED. BASED ON AVAILABLE INFORMATION, THE GYNECOLOGISTS SEND THE HIGH RISK PATIENTS TO ANOTHER INSTITUTION FOR FURTHER TESTING. HOWEVER, TESTING DETAILS PERFORMED AT THE EXTERNAL INSTITUTIONS ARE UNKNOWN. ALTHOUGH THE RISK OF PATIENT UNDERGOING UNNECESSARY AMNIOCENTESIS IS PRESENT, THE CUSTOMER STATED THERE WAS NO DEATH OR INJURY TO PATIENT OR CHANGE TO TREATMENT ATTRIBUTED OR CONNECTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER INC. DXI 800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1