DIMENSION QUIKLYTE INTEGRATED MULTISENSOR NA+ / K+ / CL-

Additional Manufacturer Narrative

A UNITED STATES CUSTOMER CONTACTED THE SIEMENS HEALTHCARE DIAGNOSTICS REMOTE SERVICES CENTER (RSC) REGARDING ERRONEOUSLY DEPRESSED SODIUM (NA) PATIENT SAMPLE RESULTS OBTAINED ON A DIMENSION EXL WITH LM INTEGRATED CHEMISTRY SYSTEM. SIEMENS HEALTHCARE DIAGNOSTICS SERVICE OPERATIONS SUPPORT (SOS) CONCLUDED THE INVESTIGATION OF THE EVENT. SOS REVIEWED THE INFORMATION PROVIDED BY THE CUSTOMER. NO REAGENT ISSUES WERE IDENTIFIED. QUALITY CONTROL (QC) WAS WITHIN THE CUSTOMER¿S ACCEPTABLE RANGES. PER SIEMENS' RECOMMENDATIONS, THE CUSTOMER PERFORMED A VARIETY OF TROUBLESHOOTING STEPS ON THE INSTRUMENT AND OBSERVED A HIGH PUMP RATE. THE CUSTOMER REPLACED THE X TUBING, MANUALLY ADJUSTED THE IMT PUMP RATE, RAN CONDITIONING, RAN A DILUTION CHECK WITH A NEW BOTTLE, AND RAN AN ADDITIONAL DILUTION CHECK. THE CUSTOMER STATED THE ISSUE WAS RESOLVED WITH THESE TROUBLESHOOTING STEPS AND NO OTHER DISCORDANT RESULTS WERE REPORTED. THE CUSTOMER IS OPERATIONAL. THE DEVICE IS PERFORMING WITHIN SPECIFICATIONS. A POTENTIAL PRODUCT ISSUE WAS NOT IDENTIFIED. NO FURTHER EVALUATION IS REQUIRED.

Description of Event or Problem

THE CUSTOMER REPORTED TO SIEMENS THEY OBTAINED ERRONEOUSLY DEPRESSED SODIUM (NA) RESULTS ON TWO (2) PATIENT SAMPLES ON A DIMENSION EXL WITH LM INTEGRATED CHEMISTRY SYSTEM. THE ERRONEOUSLY DEPRESSED RESULTS WERE REPORTED TO THE PHYSICIANS AND NOT QUESTIONED. THE SAME SAMPLES WERE REPROCESSED ON THE ORIGINAL DIMENSION EXL WITH LM INTEGRATED CHEMISTRY SYSTEM. HIGHER RESULTS WERE OBTAINED, CONSIDERED CORRECT, AND REPORTED TO THE PHYSICIANS IN AMENDED REPORTS. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY DEPRESSED SODIUM (NA) RESULTS.