Description of Event or Problem · 1
IN 2005 A HOSP LABORATORIAN REPORTED TO BAYER THAT THREE SAMPLES PRODUCED DISCREPANT RESULTS ON THE ADVIA CENTAUR TROPONIN I TEST. IN PARTICULAR, ONE OF THE SAMPLES ORIGINALLY REPORTED AS 16.5 NG/ML AND LATER DURING A SECOND TEST THE RESULT WAS <0.1 NG/ML. ORIGINALLY QC AT THIS LABORATORY WAS RUN ON A MORNING IN 2005 AND WAS WITHIN DEFINED RANGES FOR THE TROPONIN I ASSAY. THE AFOREMENTIONED PT SAMPLES WERE TESTED AND REPORTED UPON IN THE AFTERNOON. AFTER THESE SAMPLES WERE TESTED QC WAS RUN AGAIN AND THE QC MATERIAL WAS OUT OF RANGE, HIGH. THE LABORATORY TECHNICIAN ATTEMPTED TO RECALIBRATE THE SYSTEM AND THE CALIBRATION WAS SUCCESSFUL AND SUBSEQUENT QC TESTING WAS WITHIN RANGE. THE SAMPLES WERE TESTED A SECOND TIME AND THE RESULTS REPORTED AS <0.1 NG/ML. BEFORE THE REPEAT TNI REPORTS COULD REACH THE TREATING PHYSICIAN THE DECISION WAS MADE TO CONDUCT A CARDIAC CATHETERIZATION, THAT DECISION BEING MADE BASED IN PART ON THE INITIAL HIGH TNI RESULT, IN CONCERT WITH OTHER CLINICAL PRESENTATIONS. IN THE OTHER CASES, NO PT INTERVENTION WERE INITIATED AT PHYSICIAN'S DISCRETION. BAYER'S INSTRUCTIONS FOR USE FOR THE TROPONIN I ASSAY INDICATE THAT, IF THE QUALITY CONTROL MATERIAL IS OUT OF RANGE, THE USER SHOULD ENSURE THE TEST WAS PERFORMED ACCORDING TO THE INSTRUCTIONS; VERIFY THE MATERIALS ARE NOT EXPIRED; VERIFY THE REQUIRED MAINTENANCE WAS PERFORMED; AND, IF NECCESARY RERUN CONTROLS OR SEEK ASSISTANCE FROM BAYER. FOR MEDICAL DEVICE REPORTING PURPOSES THIS EVENT IS CONSIDERED CLOSED.