DIMENSION® QUIKLYTE® INTEGRATED MULTISENSOR

Additional Manufacturer Narrative

A UNITED STATES CUSTOMER CONTACTED THE SIEMENS HEALTHCARE DIAGNOSTICS CUSTOMER CARE CENTER (CCC) 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 EVALUATED THE INFORMATION PROVIDED BY THE CUSTOMER AND THE AVAILABLE INSTRUMENT DATA. QUALITY CONTROL (QC) RECOVERY WAS WITHIN THE CUSTOMER¿S ACCEPTABLE RANGES. THE CAUSE OF THE EVENT IS UNKNOWN. THE CUSTOMER STATED THE ISSUE WAS RESOLVED 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 AN ERRONEOUSLY DEPRESSED SODIUM (NA) RESULT ON ONE (1) PATIENT SAMPLE ON A DIMENSION EXL WITH LM INTEGRATED CHEMISTRY SYSTEM. THE ERRONEOUSLY DEPRESSED RESULT WAS REPORTED TO THE PHYSICIAN AND QUESTIONED. THE SAME SAMPLE WAS REPROCESSED ON THE ORIGINAL DIMENSION EXL WITH LM INTEGRATED CHEMISTRY SYSTEM AND ON AN ALTERNATE DIMENSION EXL WITH LM INTEGRATED CHEMISTRY SYSTEM. HIGHER RESULTS WERE OBTAINED ON BOTH SYSTEMS, CONSIDERED CORRECT, AND REPORTED TO THE PHYSICIAN. A DIFFERENT SAMPLE FROM THE SAME PATIENT WAS DRAWN AND TESTED ON THE ORIGINAL DIMENSION EXL WITH LM INTEGRATED CHEMISTRY SYSTEM. HIGHER RESULTS WERE OBTAINED, CONSIDERED CORRECT, AND REPORTED TO THE PHYSICIAN. THERE IS NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY DEPRESSED SODIUM (NA) RESULT.