BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVIA 60 CT

    MDR report key: 502630 · Received December 3, 2003

    Report

    Report Number
    2432235-2003-00011
    Event Type
    Other
    Date Received
    December 3, 2003
    Date of Event
    October 24, 2003
    Report Date
    November 4, 2003
    Manufacturer
    ABX
    Product Code
    GKZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER HAD REPORTED OUT ERRONEOUSLY HIGH PLATELET COUNTS FOR TWO PATIENT SAMPLES RUN ON THE ADVIA 60 HEMATOLOGY SYSTEM. ONE PATIENT HAD AN INITIAL PLATELET COUNT OF 22000. FURTHER TESTING IN THE LABORATORY INDICATED THAT THE ACTUAL PLATELET LEVEL WAS 5000. THIS PATIENT HAD APPARENTLY BEEN TRANSFUSED FOR OTHER REASONS; THEREFORE THE ACTUAL LOW PLATELET COUNT HAD NO IMPACT ON THE PATIENT'S TREATMENT. A SECOND PATIENT HAD AN INITIAL PLATELET COUNT OF 15000. FURTHER TESTING IN THE LABORATORY INDICATED THAT THE ACTUAL PLATELET LEVEL WAS 7000. CUSTOMER REPORTED THAT A PLATELET TRANSFUSION WAS DELAYED DUE TO THE INITIAL ERRONEOUS HIGH PLATELET COUNT. THE SYSTEM CHECKS BACKGROUND COUNTS DURING STARTUP, THE SYSTEM ACCEPTS A BACKGROUND PLATELET COUNT <10000. THEREFORE BOTH PATIENT VALUES ARE WITHIN THE ACCEPTABLE BACKGROUND COUNT RANGE. A NEW ADVIA 60 SYSTEM WAS INSTALLED IN THE CUSTOMER'S LABORATORY. THERE ARE NO ADDITIONAL REPORTS OF PROBLEMS AT THE CUSTOMER SITE. THE CUSTOMER'S ADVIA 60 SYSTEM WAS RETURNED TO BAYER FOR FURTHER INVESTIGATION. FOLLOWING REPLACEMENT OF V4, A VALVE THAT CONTROLS THE FLOW OF SYSTEM CLEANSER, THE PROBLEM WAS RESOLVED. THE VALVE IS CURRENTLY CONSIDERED ROOT CAUSE AND BEING RETURNED FOR FAILURE ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA 60 CT HEMATOLOGY SYSTEM GKZ ABX * NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other