DIMENSION

Additional Manufacturer Narrative

A CUSTOMER FROM THE UNITED STATES REPORTED AN OBSERVATION OF A DEPRESSED SODIUM (NA) RESULT WHICH WAS DISCORDANT RELATIVE TO REPEAT TESTING. SIEMENS REVIEWED THE INSTRUMENT DATA AND THE INFORMATION PROVIDED BY THE CUSTOMER. REAGENT AND INSTRUMENT ISSUES WERE RULED OUT BASED ON QUALITY CONTROL (QC) RECOVERY WITHIN ACCEPTABLE RANGES AND NO ISSUES WERE REPORTED WITH OTHER PATIENT SAMPLES. THE CUSTOMER REPLACED THE SAMPLE DILUENT AND FLUSH CONSUMABLES AND STATED THAT THEY DID NOT OBSERVE ANY LOW VOLUME, BUBBLES, OR DISCOLORATION IN THESE CONSUMABLES DURING THE EVENT. BASED ON THE AVAILABLE INFORMATION, THE CAUSE OF THE DISCORDANT RESULT WAS UNABLE TO BE DETERMINED. THE ISSUE WAS RESOLVED BY ROUTINE TROUBLESHOOTING. A PRODUCT PROBLEM WAS NOT IDENTIFIED. THE CUSTOMER IS OPERATIONAL AND NO FURTHER ACTIONS ARE REQUIRED.

Description of Event or Problem

THE CUSTOMER REPORTED AN OBSERVATION OF A DEPRESSED SODIUM (NA) RESULTS WHICH WAS DISCORDANT RELATIVE TO REPEAT TESTING WHEN USING LOT 5FD811. AN INITIAL DEPRESSED RESULT WAS OBTAINED FOR ONE (1) PATIENT SAMPLES. THE INITIAL DEPRESSED RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE SAME SAMPLE WAS THEN RETESTED ON AN ALTERNATE DIMENSION EXL SYSTEM AND OBTAINED A HIGHER RESULT. THE HIGHER RESULT WAS CONSIDERED CORRECT AND WAS REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE REPORTED EVENT.