BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 2222350 · Received August 25, 2011

    Report

    Report Number
    2050012-2011-04820
    Event Type
    Malfunction
    Date Received
    August 25, 2011
    Date of Event
    July 25, 2011
    Report Date
    July 25, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE INFORMATION WAS NOT SUPPLIED BY THE CUSTOMER. PER CUSTOMER COMPLAINT RECORD, QC DATA HAS SPORADICALLY YIELDED IN HIGH RESULTS PRIOR TO AND AFTER THE EVENT. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED FOR THIS EVENT. THE FSE MADE SEVERAL REPAIRS AND REPLACED MULTIPLE HARDWARE PARTS WHILE TROUBLESHOOTING THE PROBLEM OF HIGH TG RESULTS. A CLEAR ROOT CAUSE HAS NOT BEEN IDENTIFIED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO OBTAINING ERRONEOUSLY HIGH TRIGLYCERIDE (TG) RESULTS GENERATED BY THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM AND WERE REPORTED OUT OF THE LABORATORY. THE SAMPLES WERE RERUN YIELDING LOWER RESULTS, WHICH WERE CONSIDERED CORRECT AND AMENDED REPORTS WERE ISSUED. THE RESULTS PROVIDED BY THE CUSTOMER ARE SHOWN. THERE WAS NO CHANGE TO PATIENT TREATMENT ATTRIBUTED OR CONNECTED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. DXC 600I N/A

    Patients

    Seq Age Sex Outcome Treatment
    1