BEUDAMED
    FDA Adverse Event Summary report: N

    UNICEL® DXC 600I SYNCHRON ® CHEMISTRY ANALYZER

    MDR report key: 1896898 · Received November 11, 2010

    Report

    Report Number
    2050012-2010-01212
    Date Received
    November 11, 2010
    Date of Event
    September 2, 2010
    Report Date
    November 11, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS RUN IN A 1ML INSERT CUP. IT IS UNKNOWN IF THE SAMPLE VOLUME WAS SUFFICIENT TO RUN THE INITIAL TEST. PER CUSTOMER, THE SYSTEM HAS BEEN REPORTING INSUFFICIENT VOLUME ERRORS. A BCI FIELD SERVICE ENGINEER (FSE) FOUND THE BARREL TYPE CONNECTOR NOT PROPERLY SEATED. FSE RECONNECTED THE CABLE AND PERFORMED ALIQUOT PROBE ALIGNMENTS. THE FOLLOWING MED-WATCH REPORT IS LINKED TO THIS EVENT. 2050012-2010-00913.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO AN ERRONEOUS ELEVATED ACCUTNI RESULT ABOVE ACUTE MYOCARDIAL INFARCTION (AMI) CUT-OFF GENERATED BY THE UNICEL DXC 600I SYNCHRON CHEMISTRY ANALYZER. THE ERRONEOUS RESULT WAS REPORTED OUT OF THE LABORATORY AND THE PATIENT WAS ADMITTED TO THE HOSPITAL; HOWEVER, THE PATIENT DID NOT UNDERGO AN ANGIOGRAPHY. THE ORIGINAL SAMPLE WAS REPEATED AND A NEW REDRAWN SAMPLE WAS RUN AS WELL. LOWER RESULTS WERE OBTAINED FROM BOTH RUNS. TWO ADDITIONAL ERRONEOUS RESULTS WERE GENERATED; HOWEVER, THEY WERE NOT REPORTED OUT OF THE LABORATORY. NO INFORMATION IS AVAILABLE ON THOSE TWO SAMPLES.

    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 Hospitalization