DIMENSION VISTA CLINICAL CHEMISTRY SYSTEM

Description of Event or Problem

A FALSELY DEPRESSED PRO-BRAIN NATRIURETIC PEPTIDE (PBNP) RESULT WAS OBTAINED ON A PATIENT SAMPLE. THE RESULT WAS REPORTED TO THE PHYSICIAN. THE SAMPLE WAS REPEATED ON AN ALTERNATE DIMENSION VISTA SYSTEM AND A HIGHER RESULT WAS OBTAINED AND THE CORRECTED RESULT REPORTED. IT IS UNKNOWN IF PATIENT TREATMENT WAS ALTERED OR PRESCRIBED ON THE BASIS OF THE FALSELY DEPRESSED PBNP RESULT. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE FALSELY DEPRESSED PBNP RESULT.

Additional Manufacturer Narrative

ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE FALSELY DEPRESSED PBNP RESULT WAS A REAGENT LOADER MODULE MISALIGNMENT. A SIEMENS HEALTHCARE DIAGNOSTICS CUSTOMER CARE CENTER REPRESENTATIVE DIRECTED THE CUSTOMER TO THE NECESSARY CORRECTION. THE CUSTOMER RE-HOMED THE REAGENT STORAGE RINGS AND PERFORMED ALIGNMENTS. THE CUSTOMER CONFIRMING PROPER OPERATION BY VERIFYING REAGENT POSITIONS AND RUNNING QC. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.