Description of Event or Problem · 1
AFTER BEING NOTIFIED BY AN ENDOCRINOLOGIST THAT ONE OF THEIR PATIENTS HAD "UNUSUAL" RESULTS FOR FREE T4 AND TSH, WE REPEATED THE TESTS ON THE ORIGINAL SAMPLE IN QUESTION THE NEXT DAY AND FOUND THAT THE ORIGINALLY REPORTED RESULTS WERE INCORRECT. THE PHYSICIAN WAS NOTIFIED OF THE CORRECTED RESULTS. DURING FURTHER INVESTIGATION WE FOUND NOTHING UNUSUAL ABOUT THE SAMPLES. THERE WERE NO RELATED ERROR MESSAGES ON THE IMMULITE 2000 INSTRUMENT, AND NO NOTICEABLE DIFFERENCES WITH ANYTHING AT THE TIME OF REPEATING THE TESTS. THE INSTRUMENT MANUFACTURER'S TECHNICAL SUPPORT WAS CALLED THE SAME DAY, BUT NO IMMEDIATE CAUSE FOR THE ERROR WAS FOUND. TECHNICAL SUPPORT DOWNLOADED INFORMATION FROM OUR INSTRUMENT AND TOLD US THAT THEY WOULD LOOK INTO THE MATTER. TWO DAYS LATER THE TECHNICAL SERVICE ENGINEER RELAYED TO THE PHYSICIAN THAT THERE WERE NUMEROUS ERROR MESSAGES CONTAINED IN A LOG FILE THAT WE SHOULD HAVE BEEN ALERTED TO BUT WERE NOT. THE ENGINEER ALSO FOUND SEVERAL PARTS THAT NEEDED TO BE REPLACED AND COULD HAVE PRODUCED THE ERRONEOUS RESULTS. THESE PARTS WERE REPLACED AND ADDITIONAL QUALITY CONTROL CHECKS WERE PERFORMED. WE ARE AWARE OF ONLY ONE PATIENT THAT HAD UNNECESSARY FOLLOW-UP PROCEDURES STARTED DUE TO INITIAL INCORRECT RESULTS.