DIMENSION VISTA

Description of Event or Problem

THE CUSTOMER REPORTED THAT ERRONEOUSLY ELEVATED CARBON DIOXIDE (CO2) RESULTS WERE OBTAINED ON SIX PATIENT SAMPLES ON A DIMENSION VISTA 500 SYSTEM. FOR SAMPLE IDENTIFIERS (B)(6), THE ERRONEOUS RESULTS WERE REPORTED TO THE PHYSICIAN(S). OF THESE, THE RESULTS FOR SAMPLE IDENTIFIERS (B)(6) WERE QUESTIONED; HOWEVER, IT IS UNKNOWN WHETHER THE RESULT FOR SAMPLE IDENTIFIER (B)(6) WAS ALSO QUESTIONED. FOR THE OTHER TWO SAMPLE IDENTIFIERS (B)(6), THE INITIAL ERRONEOUS RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THESE TWO SAMPLES WERE REPROCESSED ON THE ORIGINAL SYSTEM, AND THE RESULTS WERE SIMILAR TO THE INITIAL ERRONEOUS RESULTS AND WERE DETERMINED TO BE ERRONEOUS. FOR SAMPLE IDENTIFIER (B)(6), THE SAMPLE WAS REPROCESSED ON THE ORIGINAL SYSTEM FOR TROUBLESHOOTING PURPOSES, AND THE RESULT WAS LOWER THAN INITIAL ERRONEOUS RESULT AND DETERMINED TO BE CORRECT. BUT NO CORRECTED REPORT WAS ISSUED. FOR THE OTHER FIVE SAMPLE IDENTIFIERS, THE SAMPLES WERE REPROCESSED ON AN ALTERNATE DIMENSION VISTA 500 SYSTEM, AND THE RESULTS WERE LOWER THAN THE ERRONEOUS RESULTS AND MATCHED THE PATIENT¿S CLINICAL HISTORY. FOR THESE FIVE SAMPLES, THE REPROCESSED RESULTS FROM AN ALTERNATE SYSTEM WERE REPORTED TO THE PHYSICIAN(S) AS THE CORRECT RESULTS. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY ELEVATED CO2 RESULTS.

Additional Manufacturer Narrative

A UNITED STATES (US) CUSTOMER CONTACTED A SIEMENS REMOTE SERVICES CENTER (RSC) AND REPORTED THAT ERRONEOUSLY ELEVATED CARBON DIOXIDE (CO2) RESULTS WERE OBTAINED ON SIX PATIENT SAMPLES ON A DIMENSION VISTA 500 SYSTEM. CALIBRATION WAS ACCEPTABLE ON THE DAY OF THE EVENT. QUALITY CONTROL (QC) WAS WITHIN RANGE PRIOR TO RUNNING PATIENT SAMPLES. THE CUSTOMER RAN QC AFTER THE ERRONEOUS RESULTS WERE OBTAINED, WHICH RECOVERED OUT OF RANGE. WITH SIEMENS¿ REMOTE ASSISTANCE, THE CUSTOMER PERFORMED INVESTIGATION, INCLUDING VERIFICATION OF SYSTEM PERFORMANCE, PROBE INSPECTIONS, REAGENT REPLACEMENT, AND RECALIBRATION USING THE SAME REAGENT FLEX LOT. FOLLOWING RECALIBRATION, THE CUSTOMER RAN QC, WHICH RECOVERED ACCEPTABLY. THE CUSTOMER ALSO PERFORMED PATIENT CORRELATION FOR TROUBLESHOOTING PURPOSES, WHICH PASSED. SIEMENS CONCLUDED THE INVESTIGATION OF THE EVENT. SIEMENS REVIEWED THE AVAILABLE INSTRUMENT DATA FILES, AND THE INFORMATION PROVIDED BY THE CUSTOMER. BASED ON THE AVAILABLE INFORMATION, THE REPORTED EVENT WAS ASSOCIATED WITH A TRANSIENT, NON-RECURRING PERFORMANCE VARIATION THAT WAS RESOLVED THROUGH STANDARD TROUBLESHOOTING AND RECALIBRATION. THERE WAS NO PERSISTENT SYSTEM/ASSAY MALFUNCTION OR RECURRING PERFORMANCE ISSUE WAS IDENTIFIED. SIEMENS EVALUATED THE EVENT AND DETERMINED THAT THE REPORTED EVENT WAS CAUSED BY A TRANSIENT VARIABILITY, POTENTIALLY ASSOCIATED WITH REAGENT HANDLING, REACTION WELL CONDITIONS, OR SAMPLE INTERACTION EFFECTS, RESULTING IN INTERMITTENT ERRONEOUSLY ELEVATED CO2 RESULTS. A PRODUCT PROBLEM WAS NOT IDENTIFIED. THE CUSTOMER IS OPERATIONAL. THE DEVICE IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION IS REQUIRED.