BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM

    MDR report key: 2072330 · Received April 28, 2011

    Report

    Report Number
    2050012-2011-01255
    Event Type
    Malfunction
    Date Received
    April 28, 2011
    Date of Event
    March 30, 2011
    Report Date
    March 30, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC PRIOR TO THE EVENT WAS WITHIN LAB-ESTABLISHED RANGES BUT THE LAB'S RANGE IS SET TO 3 SD FOR NA.A FIELD SERVICE ENGINEER (FSE) WENT ON-SITE AND IDENTIFIED SAMPLE TUBE GEL IN THE SAMPLE PROBES OF BOTH INSTRUMENTS. THE FSE REPLACED THE SAMPLE PROBES ON BOTH INSTRUMENTS. THE ROOT CAUSE IS ATTRIBUTED TO POOR SAMPLE QUALITY.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THAT BOTH THEIR UNICEL DXC 800 PRO SYNCHRON CLINICAL SYSTEMS GENERATED 16 FALSE LOW SODIUM (NA) RESULTS WHICH WERE REPORTED OUTSIDE OF THE LABORATORY. WHEN THE PHYSICIANS QUESTIONED THE RESULTS, THE INSTRUMENTS WERE RECALIBRATED AND THE SAMPLES WERE REPEATED. RESULTS WERE HIGHER AND THE REPORTS WERE AMENDED. THE RESULTS PROVIDED BY THE CUSTOMER ARE SHOWN IN THE ATTACHMENT. THE RESULTS CAME FROM BOTH INSTRUMENTS AND THE CUSTOMER CANNOT IDENTIFY WHICH INSTRUMENT GENERATED WHICH RESULTS. THE DETAILS OF THE OTHER INSTRUMENT ARE DOCUMENTED IN MDR #2050012-2011-01265. THERE WAS NO AFFECT TO PATIENT TREATMENT WITH REGARD TO THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1