BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEMS

    MDR report key: 1788287 · Received August 6, 2010

    Report

    Report Number
    2050012-2010-00539
    Event Type
    Malfunction
    Date Received
    August 6, 2010
    Date of Event
    July 20, 2010
    Report Date
    August 6, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOW RESULTS OCCURRED WHEN THE NUMBER OF TESTS REMAINING IN THE CARTRIDGE WAS BELOW 25-50. QC RAN AT THAT TIME WAS OUT OF RANGE LOW. ENVIRONMENTAL CAPS WERE SENT TO THE CUSTOMER. SERVICE WAS NOT DISPATCHED FOR THIS EVENT. A CLEAR ROOT CAUSE FOR THIS EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING ERRONEOUSLY LOW TOTAL PROTEIN (TP) RESULTS GENERATED BY THE UNICEL DXC 600 PRO SYNCHRON CLINICAL SYSTEMS. THE RESULTS WERE REPORTED OUT OF THE LAB. THE CUSTOMER REPLACED THE TP CARTRIDGE, RAN QC AND RE-TESTED SAMPLES WITH LOW TP RESULTS. THE REPEATED RESULTS WERE HIGHER AND WERE CONFIRMED ON A DIFFERENT ANALYZER. AMENDED REPORTS WERE ISSUED. THE CUSTOMER HAS NOT RECEIVED ANY REPORT OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ATTRIBUTED TO OR CONNECTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEMS CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. DXC 600 PRO

    Patients

    Seq Age Sex Outcome Treatment
    1