BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 1062402 · Received June 17, 2008

    Report

    Report Number
    2122870-2008-00191
    Event Type
    Other
    Date Received
    June 17, 2008
    Date of Event
    May 17, 2008
    Report Date
    June 17, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER COLLECTS SAMPLES IN 13 X 100 GREINER TUBES AND CENTRIFUGES AT 2,200 G FOR 15 MINUTES AT 22 DEGREES C. PER CUSTOMER, PATIENT SAMPLES WERE 100% FULL AND CLEAR. QC WAS WITHIN SPECIFICATIONS. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S LAB: THE FSE FOUND EVIDENCE OF GEL ON THE SAMPLE PROBE TIP AND REPLACED THE SAMPLE PROBE. THE FSE COMPLETED ALL NECESSARY ALIGNMENTS. THE FSE COMPLETED 50 REPLICATES OF THE LEVEL SENSE TEST WHICH MET SPECIFICATIONS. THE FSE PERFORMED A SYSTEM CHECK WHICH PASSED. THE FSE VERIFIED THE INSTRUMENT'S ALIGNMENT WITH ACCEPTABLE RESULTS. ALTHOUGH HARDWARE ISSUES WERE ADDRESSED BY THE FSE, 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 ERRONEOUSLY ELEVATED ACCU TNI RESULTS GENERATED BY THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM FOR TWO PATIENTS. PATIENT A: AN INITIAL ACCU TNI RESULT WAS 0.508NG/ML AND 0.125NG/ML UPON REPEAT. THE SAMPLE WAS ALIQUOTED, RE-SPUN, AND RE-ALIQUOTED AND THEN RETESTED AND A RESULT OF 0.116NG/ML WAS OBTAINED. PATIENT B: INITIALLY TWO RESULTS WERE OBTAINED: 0.806NG/ML AND 0.356NG/ML. THE SAMPLE WAS ALIQUOTED, RE-SPUN, AND RE-ALIQUOTED AND THEN TESTED ON A DIFFERENT INSTRUMENT IN THE CUSTOMER'S LAB AND A RESULT OF 0.238NG/ML WAS OBTAINED. THE ERRONEOUS RESULTS WERE REPORTED OUT OF THE LAB AND AMENDED REPORTS WERE SENT. THE CUSTOMER DID NOT REPORT 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