BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 1832481 · Received September 13, 2010

    Report

    Report Number
    2050012-2010-00738
    Event Type
    Malfunction
    Date Received
    September 13, 2010
    Date of Event
    August 21, 2010
    Report Date
    September 10, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRIOR TO THE EVENT ISE QC RESULTS WERE WITHIN THE LAB'S ESTABLISHED RANGES. THE CUSTOMER CONTACTED THE BCI HOTLINE AND WAS DIRECTED TO CLEAN THE MODULAR CHEMISTRY (MC) SAMPLE PROBE. THIS RESOLVED THE ISSUE, HOWEVER, A CLEAR ROOT CAUSE IS UNKNOWN AT THIS TIME.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING ERRONEOUSLY HIGH POTASSIUM (K), CALCIUM (CA), AND CARBON DIOXIDE (CO2) RESULTS GENERATED BY THE UNICEL DXC 800 PRO SYNCHRON CHEMISTRY ANALYZER ON TWO PATIENT SAMPLES. IN ADDITION, THE SODIUM (NA) AND CHLORIDE (CL) RESULTS OF THESE SPECIMENS WERE SUPPRESSED. NO FALSE RESULTS WERE REPORTED OUT OF THE LABORATORY. THE SAMPLES WERE REDRAWN, GIVING ACCURATE RESULTS, WHICH WERE REPORTED OUT. THE TWO ERRONEOUS ISE RESULTS ALONG WITH THE REPEATED RESULTS, PROVIDED BY THE CUSTOMER, ARE SHOWN. CUSTOMER INDICATED THAT THERE WAS NO AFFECT TO PATIENT TREATMENT IN REGARDS TO 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 NA

    Patients

    Seq Age Sex Outcome Treatment
    1