BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 1001714 · Received February 15, 2008

    Report

    Report Number
    2122870-2008-00049
    Event Type
    Malfunction
    Date Received
    February 15, 2008
    Date of Event
    January 24, 2008
    Report Date
    February 15, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    QC WAS WITHIN SPECIFICATIONS DURING THE TIME OF THE EVENT. THE SPECIMEN A WAS A SERUM TYPE, THE SPECIMEN B WAS A PLASMA TYPE. THE SAMPLES WERE COLLECTED IN GREINER, 13X100 TUBES AND WERE CENTRIFUGED AT 2,200 G FOR 10 MINS. THE SPECIMENS WERE FRESH AND WERE STORED AT ROOM TEMPERATURE. A FIELD SVC ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S LAB: THE FSE PERFORMED A CARRYOVER TESTING WITH ACCEPTABLE RESULTS. THE FSE CONDUCTED A DIAGNOSTIC TESTING WHICH FAILED. THE FSE INSPECTED THE WASH ASPIRATE PERI-PUMP TUBING AND REPLACED IT DUE TO BEING COMPRESSED. THE FSE REMOVED AND CLEANED A DIRTY WASH WHEEL. THE FSE CLEANED A DIRTY SUBSTRATE PROBE AND REPLACED DISPENSE PROBE #1 WHICH WAS BENT. THE FSE VERIFIED CORRECT ALIGNMENTS OF DISPENSE AND ASPIRATE PLATES. THE FSE PRIMED THE SYSTEM AND REPEATED DIAGNOSTIC TESTING WITH GOOD RESULTS. PER THE FSE NOTES, THE INSTRUMENT WAS "OKAY TO USE". HARDWARE ISSUES, ADDRESSED BY THE FSE, MAY HAVE CONTRIBUTED TO THIS EVENT. A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER, INC. (BCI) REGARDING ERRONEOUSLY HIGH TROPONIN (ACCU TNI) RESULTS THAT WERE GENERATED BY THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM FOR TWO PT SAMPLES. PT A: A PT SAMPLE WAS TESTED FOR ACCU TNI AND RESULTS WERE: 11.36NG/ML AND 0.041NG/ML. THE ORIGINAL SAMPLE WAS RE-TESTED AND A RESULT OF 0.037NG/ML WAS OBTAINED. THE ERRONEOUS RESULTS WERE REPORTED OUT OF THE LAB. PT B: INITIAL ACCU TNI RESULTS WERE: 0.454NG/ML AND 0.322NG/ML. THE SAMPLE WAS RE-TESTED AND REPEATED RESULTS WERE; 0.057NG/ML, 0.57NG/ML AND 0.540NG/ML. THE SAMPLE WAS TESTED ON A DIFFERENT INSTRUMENT IN THE CUSTOMER'S LAB AND GAVE RESULTS OF 0.048NG/ML AND 0.039NG/ML. THE CUSTOMER DID NOT REPORT PT INJURY REQUIRING MEDICAL INTERVENTION, OR CHANGE TO PT 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 DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA