ONE (1) DISCORDANT HIGH IMMULITE 2000 OV RESULT WAS OBTAINED ON ONE PATIENT SAMPLE. THE LABORATORY HAD BEEN MONITORING A PATIENT (WITH A PRIOR HISTORY OF OVARIAN CANCER) ON A MONTHLY BASIS. THIS PATIENT HAD RECEIVED CHEMOTHERAPY WHICH MAKES CLOTTING UNPREDICTABLE. AFTER RUNNING THE PATIENT SAMPLE, THE TECHNICIANS IGNORED THE DELTA CHECK FLAG, WHICH SHOULD HAVE ALERTED THEM TO REPEAT THE SAMPLE. PATIENT RECEIVED A BIOPSY, 2 RADIOGRAPHS AND WAS SET UP FOR CHEMOTHERAPY (WHICH WAS NOT INITIATED). REPEAT RESULT THE FOLLOWING MONTH DETERMINED THAT THE PREVIOUS MONTH'S RESULT WAS DISCORDANT.
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Patient 1
THE CUSTOMER HAS REFUSED A SERVICE VISIT AS THEY FEEL THAT THIS IS A SAMPLE SPECIFIC ISSUE. A SIEMENS HEALTHCARE TECHNICAL SERVICE ENGINEER (TSE) EVALUATED THE INSTRUMENT DATA (FROM (B)(4) 2010 ONLY, INSTRUMENT DATA FILES FROM (B)(4) 2010 AND (B)(4) 2010 NOT AVAILABLE). ANALYSIS OF THE INSTRUMENT DATA INDICATE THAT THERE WERE NO ISSUES FOUND IN THE FILE. IT IS THOUGHT THAT THE ROOT CAUSE IS DUE TO USER ERROR BECAUSE THE TECHNICIANS IGNORED THE DELTA CHECK, WHICH SHOULD HAVE ALERTED THEM TO REPEAT THE SAMPLE. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.