BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNICEL DXC 600 PRO SYNCHRON CHEMISTRY ANALYZER

    MDR report key: 1200188 · Received September 24, 2008

    Report

    Report Number
    2050012-2008-00056
    Event Type
    Other
    Date Received
    September 24, 2008
    Date of Event
    August 29, 2008
    Report Date
    September 24, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLES ARE LIPEMIC. THE LEVEL OF LIPEMIA IS NOT KNOWN. SAMPLES ARE NOT AVAILABLE FROM CUSTOMER. WHEN THE CUSTOMER RECEIVES ANOTHER SAMPLE THAT DEMONSTRATES THIS SITUATION, BCI WILL BE CONTACTED AND THE SAMPLE WILL BE INVESTIGATED BY THE CHEMISTRY DEVELOPMENT DEPARTMENT. A CLEAR ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE. ON A RECUR SITUATION LIP AND AMY SERUM LEVELS COULD HAVE BEEN REPORTED AS FALSE NEGATIVE WITHIN LEVELS THAT COULD JEOPARDIZE AND/OR DELAY THE DIAGNOSIS OF ACUTE PANCREATITIS. A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING ERRONEOUSLY LOW AMYLASE (AMY) AND LIPASE (LIP) RESULTS PRODUCED BY THE UNICEL DXC 600 PRO SYNCHRON CHEMISTRY ANALYZER. THERE IS AN ONGOING PROBLEM OF ERRONEOUSLY LOW AMY AND LIP RESULTS REPORTED ON PATIENTS WITH A CONFIRMED DIAGNOSIS OF PANCREATITIS. HOWEVER, NONE OF THE RESULTS HAVE BEEN SUPPLIED TO DATE. WHEN THE PHYSICIANS QUESTION THE RESULTS, THE SAMPLES ARE DILUTED WITH SALINE AND IN EACH CASE; HIGH AMYLASE AND LIPASE RESULTS ARE OBTAINED. THESE RESULTS ARE CONSISTENT WITH THE PATIENTS' CLINICAL CONDITION. AMENDED REPORTS ARE ISSUED. THE CUSTOMER HAS NOT RECEIVED ANY REPORT OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OF 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 CHEMISTRY ANALYZER CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER, INC. DXC800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA