D
Patient 1
THE CUSTOMER RECEIVED ANALYZER ALARMS AND DISCOVERED QUESTIONABLE RESULTS FOR CK-MB, TROPONIN I AND N-TERMINAL PRO B-TYPE NATRIURETIC PEPTIDE (PRO-BNP) FOR AN UNKNOWN NUMBER OF PATIENT SAMPLES. OF THE DATA PROVIDED, ONLY THE RESULTS FOR THE FOLLOWING FOUR PATIENT SAMPLES WERE DISCREPANT AND REPORTED OUTSIDE THE LABORATORY. PATIENT SAMPLE 1 INITIAL TROPONIN I RESULT WAS 25.00 NG/ML WITH A DATA FLAG. THE REPEAT RESULT ON THE SAME ANALYZER WITH A 1:10 DILUTION WAS 38.43 NG/ML WITH A DATA FLAG. THE SAMPLE WAS REPEATED ON COBAS E601 ANALYZER SERIAL NUMBER (B)(4) AND THE RESULT WAS 25.00 NG/ML WITH A DATA FLAG. THE REPEAT RESULT WITH A 1:10 DILUTION WAS 137.6 NG/ML. THE PATIENT WAS NOT ADVERSELY AFFECTED. PATIENT SAMPLE 2 WAS FROM A (B)(6) FEMALE PATIENT. THE INITIAL PRO- BNP RESULT WAS 56.65 PG/ML. THE REPEAT RESULT ON COBAS E601 ANALYZER SERIAL NUMBER (B)(4) ON (B)(6) 2013 WAS 157.1 PG/ML. THE REPEAT RESULT ON THE ORIGINAL COBAS E601 ANALYZER ON (B)(6) 2013 WAS 157.1 PG/ML. THE PATIENT WAS NOT ADVERSELY AFFECTED. PATIENT SAMPLE 3 WAS FROM A (B)(6) FEMALE PATIENT. THE INITIAL TROPONIN I RESULT ON COBAS E601 ANALYZER SERIAL NUMBER (B)(4) WAS 14.83 NG/ML WITH A DATA FLAG. ON (B)(6) 2013, THE SAMPLE WAS REPEATED ON COBAS E601 ANALYZER SERIAL NUMBER (B)(4) AND THE RESULT WAS 25.00 NG/ML WITH A DATA FLAG. THE REPEAT RESULT ON THE SAME ANALYZER WITH A 1:10 DILUTION WAS 48.69 NG/ML WITH A DATA FLAG. THE PATIENT WAS NOT ADVERSELY AFFECTED. PATIENT SAMPLE 4 WAS FROM A (B)(6) MALE PATIENT. THE INITIAL TROPONIN I RESULT WAS 1.89 NG/ML. THE REPEAT RESULT WAS