DXH 500 HEMATOLOGY ANALYZER

Additional Manufacturer Narrative

THE BEC FIELD SERVICE ENGINEER (FSE) WENT TO THE CUSTOMER SITE AND INSPECTED THE INSTRUMENT. THE FSE CONFIRMED THE CUSTOMER'S REPORTED ISSUE AND IDENTIFIED PLATELET (PLT) BACKGROUND COUNTS NOT RECOVERING WITHIN SPECIFICATION. THE FSE REPLACED THE RBC ELECTRODE AND PERFORMED PRESSURE ADJUSTMENTS RESOLVING THE EVENT. THE FSE RETURNED TO PERFORM PREVENTATIVE PART REPLACEMENTS INCLUDING THE RINSE HEAD, ASPIRATION PROBE AND RBC COUNT O-RING ALONG WITH TIGHTENING THE BATHS AND SOLENOIDS AND PERFORMING A SHUTDOWN. THE INSTRUMENT WAS VERIFIED WITH DAILY CHECKS AND REPEATABILITY. ALL RECOVERED WITHIN SPECIFICATION AND WITHOUT ERROR. BEC INTERNAL IDENTIFIER - (B)(4).

Description of Event or Problem

THE CUSTOMER REPORTED THAT PATIENT SAMPLES ARE RECOVERING WITH ERRONEOUS HIGH PLATELET (PLT) RESULTS WHEN CYCLED ON THEIR DXH500 HEMATOLOGY INSTRUMENT. NO REPORT OF ERRONEOUS RESULTS SENT OUT OF THE LABORATORY. THERE WERE NO ERRONEOUS RESULTS BEING REPORTED OUTSIDE THE LABORATORY. THERE WAS NO REPORT OF ANY INJURIES, DEATHS, OR DELAYS/CHANGES IN TREATMENT OR DIAGNOSIS TO PATIENT OR USER. PATIENT DATA WAS NOT PROVIDED FOR REVIEW. ON SITE SERVICE WAS SCHEDULED.