BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEM

    MDR report key: 2173461 · Received July 23, 2011

    Report

    Report Number
    2050012-2011-03401
    Event Type
    Malfunction
    Date Received
    July 23, 2011
    Date of Event
    June 19, 2011
    Report Date
    June 19, 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
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC WAS WITHIN THE ESTABLISHED RANGES BEFORE THE EVENT. THE CUSTOMER CHECKED THE SAMPLE FOR POSSIBLE INTERFERENCE. SERVICE TROUBLESHOT WITH THE CUSTOMER OVER THE PHONE AND HAD THE CUSTOMER FLUSH THE SAMPLE PROBE. THE CUSTOMER DID NOT REPORT ANY OTHER ISSUES SINCE THEN.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) IN REGARDS TO AN ERRONEOUSLY HIGH ASPARTATE AMINOTRANSFERASE (AST) RESULT OF 138 IU/L GENERATED BY UNICEL DXC 600 PRO SYNCHRON CHEMISTRY ANALYZER FOR ONE PATIENT'S PLASMA SAMPLE. THE RESULT WAS NOT REPORTED OUT OF THE LABORATORY. AST TEST PERFORMED PREVIOUSLY ON THE PATIENT'S SERUM SAMPLE PRODUCED A LOWER RESULT OF 20 IU/L. THE REPEAT TESTING PERFORMED ON BOTH PLASMA AND SERUM SAMPLES PRODUCED LOWER RESULTS OF 25 AND 23/21 IU/L, RESPECTIVELY. THERE WAS NO CHANGE TO PATIENT TREATMENT OR DIAGNOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER, INC. DXC 600 PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1