ANALYTICAL P MODULE

Description of Event or Problem

THE USER RECEIVED DISCREPANT CALCIUM RESULTS FOR SEVERAL PT SAMPLES. THE SAMPLES WERE ALL DRAWN IN BD TUBES (B) (4) SST 7.5 ML WITH GEL SEPARATOR. THREE EXAMPLES WERE PROVIDED. ALL RESULTS ARE IN MG/DL. SAMPLE 1 INITIAL RESULT WAS 7.4 AND WAS ACCOMPANIED BY A DATA FLAG ALERTING THE USER THE RESULT MET REPEAT CRITERIA DEFINED BY THE USER. THE SAME SAMPLE WAS REPEATED, AND A RESULT OF 8.5 WAS RECEIVED. SAMPLE 2 INITIAL RESULT WAS 8.2 AND THE FIRST REPEAT RESULT WAS 6.9. BOTH RESULTS WERE ACCOMPANIED BY DATA FLAGS ALERTING THE USER THE RESULT MET REPEAT CRITERIA DEFINED BY THE USER. THE SAMPLE WAS REPEATED AGAIN AND A RESULT OF 8.4 WAS RECEIVED. SAMPLE 3 INITIAL RESULT WAS 7.5, FIRST REPEAT RESULT WAS 6.6 AND SECOND REPEAT RESULT ON (B) (6)2009, WAS 7.4. ALL THREE RESULTS WERE ACCOMPANIED BY DATA FLAGS ALERTING THE USER THE RESULT MET REPEAT CRITERIA DEFINED BY THE USER. THE SAMPLE WAS REPEATED AGAIN ON (B) (6)2009, AND A RESULT OF 7.3 WAS RECEIVED ACCOMPANIED BY THE SAME DATA FLAG. NO ERRONEOUS RESULTS WERE REPORTED.

Additional Manufacturer Narrative

THE FIELD SERVICE REP WAS UNABLE TO DETERMINE A CAUSE. HE REPLACED THE REAGENT PROBES AND NOTED THE R2 STIRRER HAD A SUBSTANCE ON IT AND A SMALL CHIP ON THE EDGE. HE PERFORMED CHECKS ON THE FLUIDIC PRESSURES, VACUUM AND PROBE ALIGNMENTS, HIGH CONCENTRATION WASTE VALVES, TUBINGS, RINSE NOZZLES AND SQUEEGEES. TO VERIFY THE ANALYZER OPERATION, HE RAN A PRECISION WITH ACCEPTABLE RESULTS.