BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 2071309 · Received April 27, 2011

    Report

    Report Number
    2050012-2011-01324
    Event Type
    Malfunction
    Date Received
    April 27, 2011
    Date of Event
    March 27, 2011
    Report Date
    March 28, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE CUSTOMER, SAMPLE 1 NOTICED TO HAVE CLOTS IN IT WHILE REFRIGERATED AFTER SAMPLE RUN. SAMPLE 2 WAS NORMAL LOOKING AFTER SAMPLE WAS RUN. NO MENTION OF CALIBRATION OR QC PROBLEMS BY THE CUSTOMER. THE CUSTOMER CLEANED THE GLUCOSE CUP ASSEMBLY AND IT APPEARED (ABNORMALLY) YELLOW IN COLOR. ELECTRODE FACE WAS CLEANED. MONTHLY MAINTENANCE IS PERFORMED WEEKLY BY THE CUSTOMER. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND REPLACED THE GLUCOSE MODULE. THE MODULE HAS BEEN RETURNED TO BCI FACILITY FOR FURTHER EVALUATION. ROOT CAUSE REMAINS UNKNOWN AT THIS TIME.

    Description of Event or Problem · 1

    A GLUCOSE POST-MOD CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI), REPORTING TWO (2) ERRONEOUSLY HIGH GLUCOSE (GLUCM) PATIENT RESULTS THAT WERE GENERATED BY THE UNICEL DXC 800 PRO SYNCHRON CHEMISTRY ANALYZER WHILE RUNNING IN DUPLICATE MODE. THE GLUCOSE POST-MOD ACCOUNT IS MONITORED THROUGH (B)(4). PATIENT TREATMENT WAS NOT AFFECTED IN THIS EVENT AS THE CUSTOMER RUNS GLUCOSE SAMPLES IN DUPLICATE MODE AND VERIFIES RESULTS PRIOR TO REPORTING.

    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 NA

    Patients

    Seq Age Sex Outcome Treatment
    1