BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEMS

    MDR report key: 2093927 · Received May 18, 2011

    Report

    Report Number
    2050012-2011-01699
    Event Type
    Malfunction
    Date Received
    May 18, 2011
    Date of Event
    April 14, 2011
    Report Date
    April 18, 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
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DID NOT REPORT THE LOW NA RESULT TO BCI UNTIL (B)(6) 2011. QC INFORMATION WAS REQUESTED, BUT NOT PROVIDED. THE EVENT OCCURRED DURING THE SAME TIME A LEAK WAS OBSERVED FROM THE SAMPLE PROBE. IT IS BELIEVED THAT THIS SAMPLE BECAME DILUTED DUE TO THE LEAK. THE CUSTOMER COULD NOT SUPPLY ANY OTHER DETAILS. A CLEAR ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED. NOTE: A SEPARATE MDR (2050012-2011-01410) WAS FILED ON (B)(4), 2011 FOR A LEAK OBSERVED FROM THE SAMPLE PROBE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING A SODIUM (NA) RESULT OF 115MEG/L GENERATED BY THE UNICEL DXC 800 PRO SYNCHRON CLINICAL SYSTEM FOR ONE PATIENT. THE SAMPLE WAS NOT RERUN, BUT IS BELIEVED TO BE ERRONEOUS. THE TRUE VALUE IS UNKNOWN AS IT WAS NOT RERUN OR REDRAWN. THE RESULT WAS NOT REPORTED OUT OF THE LAB. PATIENT TREATMENT WAS NOT AFFECTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1