DIMENSION®

Description of Event or Problem

THE CUSTOMER REPORTED TO SIEMENS THAT AN ERRONEOUSLY DEPRESSED SODIUM (NA) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A DIMENSION EXL WITH LM SYSTEM. THE INITIAL DEPRESSED RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE SAME SAMPLE WAS REPROCESSED ON AN ALTERNATE DIMENSION EXL 200 SYSTEM AND OBTAINED A HIGHER RESULT. THE HIGHER RESULT MATCHED THE CLINICAL PICTURE OF THE PATIENT, CONSIDERED CORRECT AND WAS REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY DEPRESSED NA RESULT.

Additional Manufacturer Narrative

A UNITED STATES (US) CUSTOMER CONTACTED THE SIEMENS HEALTHCARE DIAGNOSTICS REMOTE SERVICES CENTER (RSC) AND REPORTED THAT AN ERRONEOUSLY DEPRESSED SODIUM (NA) RESULT WAS OBTAINED ON A DIMENSION EXL WITH LM SYSTEM. SIEMENS CONCLUDED THE INVESTIGATION OF THE EVENT. SIEMENS REVIEWED THE AVAILABLE INSTRUMENT DATA FILES AND THE INFORMATION PROVIDED BY THE CUSTOMER. A REVIEW OF THE INSTRUMENT DATA INDICATED THAT THE CALIBRATION WAS ACCEPTABLE, QUALITY CONTROL (QC) RECOVERY WAS WITHIN THE CUSTOMER¿S EXPECTED RANGES INDICATING THAT THE NA ASSAY WAS PERFORMING ACCEPTABLY. THE CUSTOMER REPLACED THE SALT BRIDGE SOLUTION, PRIMED ALL INTEGRATED MULTISENSOR TECHNOLOGY (IMT) CONSUMABLES, RERUN SAME PATIENT SAMPLES WHICH RECOVERED ACCEPTABLY. THE CAUSE OF THE EVENT IS CONSISTENT WITH FLOW ISSUE THROUGH IMT SYSTEM AND TUBINGS WITH THE FORMATION OF SAMPLE/ FIBRIN CLOT, CRYSTAL FORMATION, WHICH WAS RESOLVED BY PRIMING ALL IMT CONSUMABLES. THE CUSTOMER IS OPERATIONAL. THE DEVICE IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION IS REQUIRED.