BEUDAMED
    FDA Adverse Event Summary report: N

    UNICEL® DXC 600I SYNCHRON ® CHEMISTRY ANALYZER

    MDR report key: 1853413 · Received October 5, 2010

    Report

    Report Number
    2050012-2010-00917
    Date Received
    October 5, 2010
    Date of Event
    September 7, 2010
    Report Date
    October 4, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLES WERE IN LITHIUM HEPARIN GEL TUBES, CENTRIFUGED AT 3700 RPM FOR 5 MINUTES. ALL SAMPLES WERE RUN FROM PRIMARY TUBES THROUGH THE CLOSE TUBE ACCESSION (CTA). PER CUSTOMER, THE TROPONIN QC LOW LEVEL WAS OUT OF RANGE AND CALIBRATION DID NOT PASS. A BCI FIELD SERVICE ENGINEER (FSE) CHECKED THE ACCESS 2 INSTRUMENT, WHICH MET SPECIFICATION. THE CTA VERIFICATION TESTING FAILED. FSE REPLACED THE CTA SAMPLE PROBE. THE UNIT IS OPERATING AS INTENDED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO AN ERRONEOUS ELEVATED ACCUTNI RESULTS ABOVE ACUTE MYOCARDIAL INFARCTION (AMI) CUT-OFF GENERATED BY THE UNICEL DXC 600I SYNCHRON CHEMISTRY ANALYZER. THE ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. IT IS UNKNOWN IF PATIENT TREATMENT WAS IMPACTED BY THIS EVENT. THE SAMPLES WERE REPEATED AND LOWER RESULTS WERE OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600I SYNCHRON ® CHEMISTRY ANALYZER CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1