BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 2060393 · Received April 15, 2011

    Report

    Report Number
    2050012-2011-01156
    Event Type
    Malfunction
    Date Received
    April 15, 2011
    Date of Event
    March 15, 2011
    Report Date
    March 16, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLE INFORMATION WAS PROVIDED AND NO SAMPLE ISSUES WERE NOTED. CUSTOMER INDICATED THAT QC RESULTS WERE WITHIN SPECIFICATIONS. NO SYSTEM ISSUES WERE NOTED. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED FOR THIS EVENT. THE FSE PERFORMED TROUBLESHOOTING AND REPLACED MULTIPLE HARDWARE PARTS AND PERFORMED ALL THE NECESSARY ALIGNMENTS. THE FSE ALSO PERFORMED ROUTINE REPAIRS AND VERIFIED QC. THIS RESOLVED THE ISSUE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO OBTAINING FALSELY HIGH MAGNESIUM (MG) RESULTS THAT WERE GENERATED BY THE UNICEL DXC 800 PRO SYNCHRON CHEMISTRY ANALYZER. ONE OF THE ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY; HOWEVER, THE CUSTOMER DID NOT INDICATE WHICH SAMPLE RESULT WAS REPORTED OUT. CUSTOMER INDICATED THAT PATIENT TREATMENT WAS NOT AFFECTED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. DXC 800 PRO N/A

    Patients

    Seq Age Sex Outcome Treatment
    1