D
Patient 1
THE CUSTOMER ALLEGED THEY RECEIVED QUESTIONABLE MB ISOENZYME OF CREATINE KINASE (CK-MB) RESULTS ON THEIR E601 ANALYZER. THE CUSTOMER STATED THEY HAD TWO PATIENTS WITH DISCREPANT RESULTS THAT WERE REPORTED OUTSIDE THE LABORATORY. THE CUSTOMER NOTICED THE DISCREPANCY WHILE PERFORMING A PATIENT COMPARISON TO SWITCH TO THE CK-MB STAT REAGENT. THE REPEAT TESTING WAS PERFORMED ON (B)(6) 2012 ON THE ORIGINAL C601 ANALYZER AND A COBAS 8000 E602 ANALYZER, SERIAL NUMBER NOT PROVIDED. THE FIRST PATIENT'S INITIAL CK-MB RESULT WAS 1.54 NG/ML. THE REPEAT CK- MB RESULT FROM THE E601 ANALYZER WAS 7.55 NG/ML. THE REPEAT CK-MB RESULT FROM THE E602 ANALYZER WAS 7.60 NG/ML. THE SECOND PATIENT'S INITIAL CK-MB RESULT WAS 0.979 NG/ML. THE REPEAT CK-MB RESULT FROM THE E601 ANALYZER WAS 27.86 NG/ML. THE REPEAT CK-MB RESULT FROM THE E602 ANALYZER WAS 29.07 NG/ML. THE REPEAT RESULTS FROM THE E602 ANALYZER WERE CONSIDERED CORRECT AND THEY WERE ISSUED AS CORRECTED REPORTS. NO ACTION WAS TAKEN BY THE PHYSICIAN DUE TO THE DISCREPANT RESULTS. THERE WERE NO ADVERSE EVENTS. THE CK-MB REAGENT LOT NUMBER WAS 16604501 AND THE EXPIRATION DATE WAS 10/31/2012. THE FIELD SERVICE REPRESENTATIVE THOUGHT THERE MIGHT HAVE BEEN A PROBLEM WITH THE MEASURING CELL. AS THE MEASURING CELLS WERE NEARING THE END OF THEIR LIFE SPAN, HE REPLACED BOTH MEASURING CELLS ON THE ANALYZER. HE PERFORMED THE PREPARATION STEPS FOR THE NEW CELLS, DELETED PREVIOUS CALIBRATIONS, AND CALIBRATED A NEW BLANK CELL FACTOR. HE RAN PERFORMANCE TESTING WITH PASSING RESULTS. ALL ASSAYS ON BOARD WERE RECALIBRATED AND HAD QUALITY CONTROL PERFORMED WITH PASSING RESULTS.