BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 1172638 · Received September 11, 2008

    Report

    Report Number
    2122870-2008-00286
    Event Type
    Other
    Date Received
    September 11, 2008
    Date of Event
    August 26, 2008
    Report Date
    September 11, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K0203764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    THE SPECIMEN WAS TYPE PLASMA, COLLECTED IN A LITHIUM HEPARIN TUBE AND WAS CENTRIFUGED AT 3,000 RPM FOR 5 MINS. CUSTOMER NOTED A WHITE CRYSTALLIZED SUBSTANCE ON THE WASH CAROUSEL THAT APPEARS TO BE DRIED WASH BUFFER. CUSTOMER HAS HAD DIFFICULTY WITH ACCU TNI QC RECOVERING WITHIN RANGE LATELY. A CUSTOMER TECHNICAL SERVICE (CTS) HAD CUSTOMER RUN A SYSTEM CHECK WHICH FAILED. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S LAB: THE FSE PERFORMED A DIAGNOSTIC TESTING WHICH FAILED. THE FSE REPLACED: PERI-PUMP TUBING, SUBSTRATE SPINNER AND #2 SPINNER AS THEY WERE LOOSING THEIR GRIP WHILE SPINNING, AND TUBING FOR ASPIRATE PROBE #3. THE FSE PERFORMED ALIGNMENT IN THE WASH CAROUSEL AND PIPETTORS. THE FSE VERIFIED THE REPAIR PER ESTABLISHED PROCEDURES AND RESULTS MET PUBLISHED PERFORMANCE SPECIFICATIONS. ALTHOUGH HARDWARE ISSUES MAY HAVE CONTRIBUTED TO THIS EVENT, A CLEAR ROOT CAUSE HAS NOT BEEN DETERMINED TO DATE. 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 ELEVATED TROPONIN (ACCUTNI) RESULTS GENERATED BY THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM FOR A SINGLE PT SAMPLE. A PATIENT SAMPLE WAS TESTED FOR ACCU TNI AND A RESULT OF 0.54NG/ML WAS OBTAINED INITIALLY AND 0.53NG/ML UPON REPEAT. THE RESULT WAS REPORTED OUT OF THE LAB. THE SAMPLE WAS TESTED ON A DIFFERENT INSTRUMENT IN THE CUSTOMER'S LAB AND AN ACCU TNI RESULT OF 0.03NG/ML WAS OBTAINED. THE CUSTOMER DID NOT RECEIVE ANY REPORT OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT 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 MMI BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA