BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 1054738 · Received May 29, 2008

    Report

    Report Number
    2122870-2008-00162
    Event Type
    Other
    Date Received
    May 29, 2008
    Date of Event
    May 5, 2008
    Report Date
    May 29, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLES WERE COLLECTED IN BD LITHIUM HEPARIN TUBES AND WERE CENTRIFUGATED FOR 4 MINUTES. THE CUSTOMER PERFORMED MAINTENANCE IN 2008 AT WHICH TIME THE ASPIRATE PROBES WERE CHANGED. PER CUSTOMER, QC RECOVERED WITHIN RANGE. THE CUSTOMER IS NOT REPORTING PROBLEMS WITH ANY OTHER ASSAY AT THIS TIME. A FIELD SERVICE ENGINEER (FSE) WAS ONSITE THE NEXT DAY: THE FSE PERFORMED A PREVENTIVE MAINTENANCE (PM) AND HARDWARE VERIFICATION PER WRITTEN PROTOCOL. FSE REPLACED: SPRINGS AND SEALS IN PRECISION PUMPS AND SAMPLE PROBE. THE FSE RAN CARRYOVER AND PRECISION TESTING WHICH WAS WITHIN CUSTOMERS EXPECTED LIMITS. THE FSE VERIFIED THE REPAIR PEER ESTABLISHED PROCEDURES AND RESULTS MET PUBLISHED PERFORMANCE SPECS. BCI REP SPOKE TO CUSTOMER AT THE END OF THE MONTH, AND CUSTOMER STATED THEY ARE STILL RECEIVING ERRONEOUS RESULTS AND THEY HAVE A SAMPLE HANDLING ISSUE. BCI APPLICATIONS SPECIALIST CONTACTED CUSTOMER TO OFFER ASSISTANCE AND CUSTOMER DECLINED. PER CUSTOMER, THEY HAVE RECENTLY ESTABLISHED A NEW LAB PROTOCOL REGARDING RESULTS RELEASE. A CLEAR ROOT CAUSE FOR THIS EVENT 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 ERRONEOUS ACCU TNI RESULTS GENERATED BY THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM FOR FOUR (4) PATIENTS. PATIENT A: AN INITIAL ACCU TNI RESULT WAS 0.12 NG/ML AND 0.68 NG/ML UPON REPEAT. PATIENT B: AN INITIAL RESULT WAS 1.20 NG/ML AND 0.03 NG/ML UPON REPEAT. PATIENT C: FIRST SAMPLE FROM THIS PATIENT GAVE A RESULT OF 0.50 NG/ML. A FRESH SAMPLE WAS COLLECTED AND TESTED FOR ACCU TNI ON A DIFFERENT INSTRUMENT IN THE CUSTOMER'S LAB AND A RESULT OF 0.04NG/ML WAS OBTAINED. PATIENT D: THE INITIAL RESULTS WERE: 0.26 NG/ML AND 0.55 NG/ML. A NEW SAMPLE GAVE RESULTS OF 0.67 NG/ML AND 0.05 NG/ML. THE NEW SAMPLE WAS TESTED ON A DIFFERENT INSTRUMENT AND A RESULT OF 0.07 NG/ML WAS OBTAINED. IT IS UNKNOWN WHAT RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE CUSTOMER DID NOT RECEIVE ANY REPORT OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR CONNECTED TO 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