BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON CX5 DELTA CLINICAL SYSTEM

    MDR report key: 2060517 · Received April 18, 2011

    Report

    Report Number
    2050012-2011-01201
    Event Type
    Malfunction
    Date Received
    April 18, 2011
    Date of Event
    March 18, 2011
    Report Date
    March 18, 2011
    Manufacturer
    BECKMAN COULTER INC
    Product Code
    JJE
    PMA / PMN Number
    K881495
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLE INFORMATION WAS PROVIDED. CALIBRATION AND QC REPORTS FAXED BY CUSTOMER APPEARED TO BE WITHIN SPECIFICATIONS. CUSTOMER REPORTED NO SUPPRESSED RESULTS OR ERRORS FOR TBIL. A BCI FIELD SERVICE ENGINEER (FSE) AND PERFORMED: COMPLETED TG/GLU CARRYOVER TEST PRIOR TO COMPLETING ANY REPAIRS. REPLACED CC SAMPLE PROBE AND MIXER. ALIGNMENTS TO WASH STATION AND CUVETTES. VERIFIED ALIGNMENTS TO WASH STATION AND CUVETTES. REPEATED CARRYOVER TEST. SYSTEM PASSED TEST WITHOUT ERRORS. ROUTINE REPAIRS HAVE RESOLVED THE ISSUE. CUSTOMER WILL REPEAT ANY TG ABOVE NORMAL RANGE TO VERIFY REPAIR. WILL MONITOR BY PHONE WITH CUSTOMER.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS ERRONEOUS HIGH TRIGLYCERIDE (TG) RESULTS FOR GENERATED BY SYNCHRON CX5 DELTA CLINICAL SYSTEM. THE RESULTS WERE REPORTED OUT OF THE LABORATORY. THE SAMPLES WERE REPEATED AND LOWER RESULTS WERE OBTAINED. PATIENT TREATMENT WAS NOT IMPACTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON CX5 DELTA CLINICAL SYSTEM CLINICAL CHEMISTRY ANALYZER, JJE BECKMAN COULTER INC CX 5 DELTA N/A

    Patients

    Seq Age Sex Outcome Treatment
    1