BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 972080 · Received December 20, 2007

    Report

    Report Number
    2122870-2007-00297
    Event Type
    Other
    Date Received
    December 20, 2007
    Date of Event
    December 1, 2007
    Report Date
    December 20, 2007
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE ARE COLLECTED BY NURSE STAFF INTO BD PLASTIC SERUM SEPARATOR TUBE WITH GEL AND ALL TESTING OCCURRED VIA THE PRIMARY TUBE. SAMPLES WERE SPUN FOR FIVE MINS AT 3000 RPM ON THE POWER PROCESSOR. CUSTOMER STATED THAT THEY RUN QC EVERY 24 HRS AND HAD NOT HAD ANY ISSUES PRIOR TO THE EVENT. IN 2007, THE CUSTOMER CALLED HOTLINE WITH QC ISSUES AND SEVERAL FAILED ACCU TNI CALIBRATIONS. DATA SHOWS THAT CALIBRATION FAILURES WERE DUE TO IMPRECISION OF CALIBRATORS. A FIELD SVC ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER LAB THE FOLLOWING DAY. THE FSE DISCOVERED THAT ASPIRATE PROBE#1 WAS BINDING DURING ITS DOWNWARD TRAVEL. THE FSE ADJUSTED ASPIRATED PLATE FOR PROPER OPERATION OF ALL PROBES. THE FSE CALIBRATED ACCU TNI SUCCESSFULLY AND VERIFIED QC RECOVERY WHICH WAS ACCEPTABLE. CUSTOMER PERFORMED A SMALL PT CORRELATION ON ANOTHER INSTRUMENT VERSUS THE DXI AND NO ISSUES WERE NOTED. THE FSE RETURNED FIVE DAYS LATER,TO COMPLETE TYPE I DIAGNOSTIC TESTING AND NO ISSUES WERE NOTED. THE FSE VERIFIED REPAIR PER ESTABLISHED PROCEDURES. ALTHOUGH HARDWARE ISSUES MAY HAVE CONTRIBUTED TO THIS EVENT, A CLEAR ROOT CAUSE HAS NOT BEEN DETERMINED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING ERRONEOUSLY ELEVATED TROPONIN (ACCU TNI) RESULTS FOR 65 PTS. THE ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LAB AND WERE QUESTIONED BY THE CARDIOLOGIST. THE CUSTOMER REPEATED THE SAMPLES AND DISCOVERED THAT ALL WERE FALSELY ELEVATED. IT IS UNK IF ACCU TNI RESULTS WERE ABOVE OR BELOW THE AMI CUTOFF VALUE OF 0.50NG/ML AS DATA WAS NOT PROVIDED. UPON REVIEW OF ARCHIVED DATA, IT IS NOT CLEAR WHICH SAMPLES WERE QUESTIONED AND FOUND ERRONEOUS. BASED ON AVAILABLE INFO, 8 OF THE 65 PTS WERE ADMITTED DUE TO THE ERRONEOUS RESULTS. NO REPORT OF DEATH OR SERIOUS INJURY HAS BEEN RECEIVED FOR THIS EVENT. THE CUSTOMER HAS NOT CONFIRMED IF CHANGE OF TREATMENT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER MMI BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA YR