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Patient 1
THE USER STATED THAT SHE HAD BEEN USING CALCIUM REAGENT LOT 616892-01 WITH NO PROBLEMS, BUT SHE RAN OUT AND PUT OLD LOT 613188-01 ONTO THE ANALYZER. SHE RAN 12 PATIENT PLASMA SAMPLES AND THE RESULTS "WERE OFF". SHE STATED AFTER REPLACING THE REAGENT WITH LOT 616892-01, SHE RERAN THE PATIENT SAMPLES AND THE RESULTS WERE ACCEPTABLE. THE USER PROVIDED RESULTS FOR ELEVEN PATIENT SAMPLES, OF WHICH NINE WERE DISCREPANT. ALL RESULTS ARE IN MG PER DL. ON (B) (6) 2009, SAMPLE 1 INITIAL RESULT WAS 13.1, REPEAT RESULT ON THE SAME LOT WAS 11.1. SAMPLE 2 INITIAL RESULT WAS 10.9, REPEAT RESULT ON THE SAME LOT WAS 9.6. ON (B) (6) 2009, SAMPLE 3 INITIAL RESULT WAS 11.0, REPEAT RESULT ON THE SAME LOT WAS 9.9. SAMPLE 4 INITIAL RESULT WAS 11.8, REPEAT RESULT ON THE SAME LOT WAS 10.2. ON (B) (6) 2009, SAMPLE 5 INITIAL RESULT WAS 11.2, REPEAT RESULT ON THE SAME LOT WAS 9.6. SAMPLE 6 INITIAL RESULT WAS 10.2, REPEAT RESULT ON THE SAME LOT WAS 11.4, REPEAT RESULT ON LOT 616892-01 WAS 9.6. SAMPLE 7 INITIAL RESULT WAS 10.2, REPEAT RESULT ON THE SAME LOT WAS 9.6, REPEAT RESULT ON LOT 616892-01 WAS 9.1. SAMPLE 8 INITIAL RESULT WAS 10.2, REPEAT RESULT ON THE SAME LOT WAS 10.0, REPEAT RESULT ON LOT 616892-01 WAS 9.2. SAMPLE 9 INITIAL RESULT WAS 10.5, REPEAT RESULT ON THE SAME LOT WAS 9.8, REPEAT RESULT ON LOT 616892-01 WAS 9.5. THE USER STATED SHE REPORTED THE LOWEST RESULT FROM THE ORIGINAL AND RERUNS FOR ALL 12 PATIENT SAMPLES. NO ADVERSE REACTION OCCURRED FORM THE REPORTING OF THESE RESULTS.