BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM

    MDR report key: 1942640 · Received December 30, 2010

    Report

    Report Number
    2050012-2010-01762
    Event Type
    Malfunction
    Date Received
    December 30, 2010
    Date of Event
    November 10, 2010
    Report Date
    December 1, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER STATED THAT QC IS LOW WHEN RERUN AFTER LOW SODIUM (NA) RESULTS ARE NOTICED. IF THE ANION GAP IS LOW, THEN THE SAMPLES ARE RERUN. THE ANION GAPS WERE 4-5 UNITS LOWER ON THIS INSTRUMENT FOR THE SAMPLES. A BCI FIELD SERVICE ENGINEER NOTED ON (B)(4) 2010 THAT THE CUSTOMER HAD CHANGED THE NA MEASURING ELECTRODE AND IT APPEARED TO HAVE RESOLVED THE ISSUE. THE FSE VISITED THE SITE ON (B)(4) 2010, AND PERFORMED VERIFICATION TEST. ON (B)(4) 2010, THE FSE DECONTAMINATED THE INSTRUMENT, REPLACED NA AND CARBONE DIOXIDE (CO2) ELECTRODES, SAMPLE PROBE, AND WASH COLLAR.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO ERRONEOUSLY LOW SODIUM (NA) RESULTS INTERMITTENTLY GENERATED BY UNICEL DXC 800 PRO SYNCHRON CLINICAL SYSTEM BETWEEN (B)(6) 2010 AND (B)(6) 2010. THE RESULTS WERE REPORTED OUT OF THE LABORATORY. RERUNS WERE TRIGGERED BY LOW ANION GAPS. THE REPEAT RESULTS AGREED WITH ANOTHER INSTRUMENT IN THE LAB. BOTH INITIAL AND REPEAT RESULTS WERE ALL WITHIN THE NORMAL REFERENCE RANGE. PATIENT TREATMENT WAS NOT INITIATED OR WITHHELD UPON THE ERRONEOUS RESULTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM CLINICAL CHEMSTRY ANALYZER JJE BECKMAN COULTER, INC. DXC 800 PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1