DIMENSION

Additional Manufacturer Narrative

A UNITED STATES (US) CUSTOMER CONTACTED A SIEMENS CUSTOMER CARE CENTER (CCC) AND REPORTED THAT AN ERRONEOUSLY DEPRESSED N-TERMINAL PRO-BRAIN NATRIURETIC PEPTIDE (NT-PROBNP) RESULT WAS OBTAINED ON A DIMENSION EXL WITH LM INTEGRATED CHEMISTRY SYSTEM. SIEMENS REVIEWED THE SYSTEM DATA AND FOUND THAT THE QUALITY CONTROL (QC) AND CALIBRATION WAS ACCEPTABLE ON THE DAY OF THE EVENT. CLOT CHECK DATA SHOWED SLIGHT VARIATIONS IN PRESSURE READINGS BETWEEN THE INITIAL ERRONEOUS AND THE REPEAT CORRECT RESULTS. A CUSTOMER SERVICE ENGINEER (CSE) VISITED THE SITE, ASSESSED SYSTEM PERFORMANCE, VERIFIED HETEROGENOUS MODULE (HM) TEMPERATURE, MIXER VOLTAGES, SYRINGE GAPS, PUMP PERFORMANCE, AND RAN SYSTEM CHECKS AND QC, ALL OF WHICH WERE ACCEPTABLE. A PRODUCT PROBLEM WAS NOT IDENTIFIED. BASED ON THE AVAILABLE INFORMATION, THE CAUSE OF THE EVENT IS UNKNOWN. THE CUSTOMER IS OPERATIONAL. THE INSTRUMENT IS WORKING ACCORDING TO THE SPECIFICATIONS. NO FURTHER EVALUATION IS REQUIRED.

Description of Event or Problem

THE CUSTOMER REPORTED THAT AN ERRONEOUSLY DEPRESSED N-TERMINAL PRO-BRAIN NATRIURETIC PEPTIDE (NT-PROBNP) RESULT WAS OBTAINED ON A DIMENSION EXL WITH LM INTEGRATED CHEMISTRY SYSTEM. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED THRICE ON AN ALTERNATE DIMENSION EXL WITH LM INTEGRATED CHEMISTRY SYSTEM AND OBTAINED HIGHER RESULTS. THE REPEAT RESULTS MATCHED THE PATIENT¿S CLINICAL HISTORY, AND ONE OF THE RESULTS WAS REPORTED TO THE PHYSICIAN(S) AS CORRECT RESULT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUS NT-PROBNP RESULT.