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

Additional Manufacturer Narrative

A UNITED STATES (US) CUSTOMER CONTACTED THE SIEMENS HEALTHCARE DIAGNOSTICS REMOTE SERVICES CENTER (RSC) REGARDING AN ERRONEOUSLY DEPRESSED SODIUM (NA) PATIENT SAMPLE RESULT 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 AND THE DATA FROM THE INSTRUMENT. NO REAGENT OR INSTRUMENT ISSUES WERE IDENTIFIED. THE CUSTOMER OBSERVED A CONSUMABLE EMPTY MESSAGE FOR STD A (QUIKLYTE STANDARD A). THE CUSTOMER REPLACED THE STD A AND OBSERVED ERRONEOUSLY DEPRESSED RESULTS. THE CUSTOMER RERAN THE QUALITY CONTROL (QC) WHICH RECOVERED LOW OUT OF THE LABORATORY RANGE. THE CUSTOMER THEN PRIMED STD A AT LEAST 10X AND RERAN THE QC WHICH RECOVERED WITHIN RANGE. SOS REVIEWED THE INSTRUMENT DATA FILES AND FOUND LOW FLOW FOR STD A FLUID. THIS SUGGESTS A FLOW ISSUE IN THE STD A TUBING, POSSIBLY DUE TO BUBBLES, DEBRIS, BUILDUP OR WEAR. THE DEPRESSED SODIUM (NA+) RESULT IS CONSISTENT WITH THIS ISSUE, WHICH WAS RESOLVED BY PRIMING STD A DURING ROUTINE TROUBLESHOOTING. A POTENTIAL PRODUCT ISSUE WAS NOT IDENTIFIED. THE CUSTOMER IS OPERATIONAL. THE DEVICE IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION IS REQUIRED.

Description of Event or Problem

THE CUSTOMER REPORTED TO SIEMENS AN ERRONEOUSLY DEPRESSED SODIUM (NA+) RESULT OBTAINED ON ONE (1) PATIENT SAMPLE ON A DIMENSION EXL WITH LM INTEGRATED CHEMISTRY SYSTEM. THE ERRONEOUSLY DEPRESSED RESULT WAS REPORTED TO THE PHYSICIAN AND NOT QUESTIONED. THE SAME SAMPLE WAS REPROCESSED ON AN ALTERNATE DIMENSION EXL WITH LM INTEGRATED CHEMISTRY SYSTEM. A HIGHER RESULT WAS OBTAINED, CONSIDERED CORRECT AND NOT REPORTED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY DEPRESSED SODIUM (NA+) RESULT.