BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 1984305 · Received February 10, 2011

    Report

    Report Number
    2050012-2011-00412
    Event Type
    Malfunction
    Date Received
    February 10, 2011
    Date of Event
    January 28, 2011
    Report Date
    January 28, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    DHR
    PMA / PMN Number
    K042291
    Removal / Correction Number
    2050012-06/21/2010-017C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE INFORMATION NOT PROVIDED PER CUSTOMER: NO SYSTEM ISSUES OR ERRORS HAVE BEEN NOTED. CONTROLS HAVE BEEN WITHIN THE ACCEPTABLE RANGES. SERVICE WAS NOT REQUESTED AS THIS EVENT APPEARS TO BE A REAGENT ISSUE. A NEW RF REAGENT LOT (LOT# M007324) WAS SENT TO THE CUSTOMER AND THE RESULTS OBTAINED ARE BETTER. THE ROOT CAUSE IS STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO AN ERRONEOUS POSITIVE RHEUMATOID FACTOR (RF) RESULTS ON ONE PATIENT GENERATED BY THE UNICEL DXC 600 PRO SYNCHRON CHEMISTRY ANALYZER. THE ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY AND QUESTIONED BY THE PHYSICIAN. . THE SAMPLES WERE SENT TO AN ALTERNATE REFERENCE LAB FOR REPEAT TESTING. IN ADDITION, THE SAMPLE WAS RUN WITH RF REAGENT (RGT) LOT# M007324. THE CUSTOMER HAS NOT RECEIVED ANY REPORTS OF PATIENT CONSEQUENCES DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600 PRO SYNCHRON® CHEMISTRY ANALYZER CLINICAL CHEMISTRY ANALYZER, DHR BECKMAN COULTER INC. N/A RF RGT LOT # M004772

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR