ANALYTICAL D MODULE

Description of Event or Problem

USER EXPERIENCING A DOWNWARD SHIFT IN CALCIUM RESULTS FOR APPROX 30 PT SAMPLES. THE FOLLOWING FOUR PT EXAMPLES PROVIDED WERE DISCREPANT. REPEAT TESTING WAS PERFORMED ON A DIFFERENT D MODULE. SAMPLE 1, INITIAL RESULT GAVE 1.3 MG PER DL. THIS RESULT WAS ACCOMPANIED BY A DATA FLAG ALERTING THE USE THE RESULT WAS UNDER THE NORMAL VALUE LIMIT. REPEAT FOR THIS SAMPLE GAVE 8.9 MG PER DL. SAMPLE 2 INITIAL RESULT GAVE 1.1 MG PER DL. THIS RESULT WAS ACCOMPANIED BY A DATA FLAG ALERTING THE USE THE RESULT WAS UNDER THE NORMAL VALUE LIMIT. REPEAT FOR THIS SAMPLE GAVE 9.3 MG PER DL. SAMPLE 3, INITIAL RESULT GAVE 4.9 MG PER DL. THIS RESULT WAS ACCOMPANIED BY A DATA FLAG ALERTING THE USE THE RESULT WAS UNDER THE NORMAL VALUE LIMIT. REPEAT FOR THIS SAMPLE GAVE 9.0 MG PER DL. SAMPLE 4, INITIAL RESULT GAVE 6.5 MG PER DL. THIS RESULT WAS ACCOMPANIED BY A DATA FLAG ALERTING THE USE THE RESULT WAS UNDER THE NORMAL VALUE LIMIT. REPEAT FOR THIS SAMPLE GAVE 9.6 MG PER DL. CUSTOMER STATES "SHE HAS RESOLVED THE PROBLEM AND DOES NOT NEED SERVICE". CUSTOMER FOUND THE CALCIUM R2 PROBE BLUE TIP HAD BEEN PARTIALLY BLOCKED AND STYLETTED OUT THE BLUE TIP, RE-PRIMED, RECALIBRATED AND CONTROLS NOW IN RANGE, WHICH HAS IMPROVED THE PERFORMANCE OF THE ASSAY.