EPOC READER, HOST

Additional Manufacturer Narrative

SIEMENS HAS REQUESTED INSTRUMENT FILES FOR FURTHER INVESTIGATION; HOWEVER, THE CUSTOMER DID NOT PROVIDE THEM. THE IN-HOUSE PERFORMANCE OF SODIUM FOR THE CARD LOT IN QUESTION WAS REVIEWED, DID NOT IDENTIFY ANY PRODUCT DEFICIENCIES. AQUEOUS FLUIDS AND ARTERIALIZED BLOOD PERFORMED AS EXPECTED AND MET PRODUCT SPECIFICATIONS AT THE TIME OF RELEASE. CARD LOT WAS ALSO TESTED THROUGHOUT LIFETIME WITH WHOLE BLOOD AGAINST COMPARATIVE INSTRUMENTS AND PERFORMED AS EXPECTED. THEREFORE, THERE IS NO EVIDENCE THAT THE SYSTEM OR REAGENT CARDS ARE NOT PERFORMING AS INTENDED. IT SHOULD BE NOTED THAT EPOC AND COMPETITOR DEVICE USE TWO DIFFERENT MEASUREMENT METHODS, DIRECT VS INDIRECT, RESPECTIVELY. PER THE MANUAL, "THE EPOC SODIUM MEASUREMENT IS AN UNDILUTED (DIRECT) METHOD. VALUES MAY DIFFER FROM THOSE OBTAINED BY DILUTIONAL (INDIRECT) METHODS." DIFFERENCES IN INSTRUMENT METHODOLOGIES CANNOT BE RULED OUT AS A ROOT CAUSE OF THE ALLEGED NA DISCREPANCIES AT THE CUSTOMER SITE. THERE WAS NO HARM, OR DELAY IN PATIENT REPORTING IMPACTING MEDICATION, PROCEDURE, TREATMENT OR INTERVENTIONS FOR A PATIENT AND/OR TO PROTECT PUBLIC HEALTH. THE CAUSE OF THIS EVENT IS UNKNOWN.

Description of Event or Problem

THE CUSTOMER REPORTED THAT THEIR EPOC INSTRUMENT GAVE A DISCREPANT HIGH SODIUM RESULT COMPARED TO RETESTING OF THE SAME SAMPLE ON A NON-SIEMENS INSTRUMENT. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.