DIMENSION VISTA® CLINICAL CHEMISTRY SYSTEM

Description of Event or Problem

A FALSELY DEPRESSED CALCIUM RESULT WAS OBTAINED ON A PATIENT SAMPLE. SEVERAL OTHER ANALYTES ON THE SAME SAMPLE WERE DEPRESSED. THE RESULTS WERE REPORTED TO THE PHYSICIAN. A NEW (REDRAW) SAMPLE WAS RUN. A HIGHER RESULT WITHIN THE NORMAL RANGE WAS OBTAINED FOR THE CALCIUM AND REPORTED. OTHER ANALYTES WERE NOT REPEATED. NO OTHER PATIENT SAMPLES WERE IMPACTED. THE PATIENT RECEIVED A IV INFUSION BASED ON THE ORIGINAL CALCIUM RESULT. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE FALSELY DEPRESSED CALCIUM RESULT.

Additional Manufacturer Narrative

ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE FALSELY DEPRESSED CALCIUM RESULT WAS ALIQUOTTER PROBE MAINTENANCE ISSUES. A SIEMENS HEALTHCARE DIAGNOSTICS INC. FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE SITE AND PERFORMED MAINTENANCE PROCEDURES. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

Additional Manufacturer Narrative

FURTHER ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE FALSELY DEPRESSED CALCIUM RESULT WAS UNKNOWN. AN INSUFFICIENT SAMPLE IS SUSPECTED. A SIEMENS HEALTHCARE DIAGNOSTICS INC. FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE SITE. NO MALFUNCTIONS WERE DETECTED. THE FSE PERFORMED MAINTENANCE. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

Description of Event or Problem

A FALSELY DEPRESSED CALCIUM RESULT WAS OBTAINED ON A PATIENT SAMPLE. THE RESULT WAS REPORTED TO THE PHYSICIAN. A NEW (REDRAW) SAMPLE WAS RUN. A HIGHER RESULT WITHIN THE NORMAL RANGE WAS OBTAINED AND REPORTED. THE PATIENT RECEIVED A IV INFUSION BASED ON THE ORIGINAL CALCIUM RESULT. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE FALSELY DEPRESSED CALCIUM RESULT.