BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 1574483 · Received January 11, 2010

    Report

    Report Number
    2050012-2010-00005
    Event Type
    Malfunction
    Date Received
    January 11, 2010
    Date of Event
    December 16, 2009
    Report Date
    April 30, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJC
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC BEFORE THE EVENT WAS WITHIN LAB'S ESTABLISHED RANGES. A FIELD SERVICE ENGINEER (FSE) WAS ON-SITE (B)(6)2009. FSE REPLACED THE SAMPLE PROBE AND ALIGNED THE PROBE ARM. NO OTHER ISSUES HAVE BEEN NOTED SINCE SERVICE VISITED. DUE TO A POTENTIAL FOR THIS EVENT TO RECUR UNKNOWINGLY, THERE IS POTENTIAL THAT A PIVOTAL ASSAY COULD BE ERRONEOUSLY REPORTED AND TREATMENT DECISION MAY BE AFFECTED. A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT.

    Description of Event or Problem · 1

    CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING FALSELY LOW RESULTS GENERATED BY THE UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER. A FALSE LOW TOTAL PROTEIN (TP) RESULT OF 2.1G/DL WAS REPORTED AND QUESTIONED BY THE PHYSICIAN. THE SAMPLE WAS RERUN AND THE RESULT WAS AMENDED TO 6.1G/DL.AN ALBUMIN (ALB) RESULT OF 4.4G/DL WAS REPORTED FOR THIS PATIENT AND UPON REPEAT, THE RESULT WAS AGAIN 4.4G/DL.A GLUCOSE (GLU) RESULT OF 20MG/DL WAS OBTAINED FOR A SECOND PATIENT AND UPON REPEAT, THE RESULT WAS 82MG/DL.THERE WAS NO AFFECT TO PATIENT TREATMENT AS A RESULT OF THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1