Description of Event or Problem · 1
THE PHOSPHORUS MODULE ON THE DXC 800 CHEMISTRY ANALYZER FAILED AFTER MAINTENANCE. THE MACHINE GENERATED INTERMITTENT INCORRECT PHOSPHORUS RESULTS FROM SERUM SAMPLES FROM MIDNIGHT UNTIL THE MODULE WAS DISABLED AT 9 AM. THE RESULTS WERE REPORTED OUT OF THE LABORATORY. SEVENTY TESTS WERE RE-RERUN. TWELVE AMENDED REPORTS WERE ISSUED. TWO PATIENTS WITH INITIAL ERRONEOUS PHOSPHORUS VALUES OF 1.9 (LOW) WERE TREATED WITH SODIUM PHOSPHATE INFUSION JUST BEFORE THE AMENDED RESULTS WERE CALLED IN. THE TREATMENTS MAY HAVE BEEN UNNECESSARY BASED ON THE ERRONEOUS INITIAL VALUES. THEIR FOLLOW-UP PHOSPHORUS VALUES WERE NORMAL. BOTH PATIENTS HAD NO COMPLICATIONS. THE MANUFACTURER, BECKMAN COULTER, WAS CONTACTED AND RESPONDED PROMPTLY. CALIBRATION APPEARED ACCEPTABLE BEFORE THE EVENT. QUALITY CONTROL FROM THE PREVIOUS WEEK RESULTED IN ONE LOW AND TWO HIGH PHOSM FLIERS. A FIELD SERVICE ENGINEER REPLACED THE PHOSM MODULE AND ASSOCIATED TUBING. A CLEAR ROOT CAUSE COULD NOT BE IDENTIFIED BY BECKMAN COULTER FOR THIS EVENT. THE MANUFACTURER ALSO FILED AN FDA REPORT #2050012-2010-00298======================MANUFACTURER RESPONSE FOR CHEMISTRY ANALYZER, UNICEL DXC 800 SYNCHRON CHEMISTRY ANALYZER (PER SITE REPORTER)======================MANUFACTURER'S RESPONSE IS INCLUDED IN THE EVENT DESCRIPTION.