DIMENSION VISTA®

Additional Manufacturer Narrative

MDR 2517506-2018-00397 WAS ALSO FILED FOR THE SAME EVENT. THE CUSTOMER CONTACTED SIEMENS HEALTHCARE DIAGNOSTICS CONCERNING A FALSELY ELEVATED FREE THYROXINE (FT4) RESULT. SIEMENS HEADQUARTERS SUPPORT CENTER (HSC) CONCLUDED THE INVESTIGATION OF THE INFORMATION PROVIDED. HSC CONCLUDED THE PATIENT SAMPLE DISCREPANT RESULT WAS CONSISTENT WITH AN INTERFERENT. IN ADDITION, SIEMENS PERFORMED TROUBLESHOOTING AND CANNOT IDENTIFY ANY ISSUES WITH INSTRUMENT PERFORMANCE. QUALITY CONTROL (QC) PROCESSED ON THE INSTRUMENT PERFORMING THE PATIENT SAMPLE TESTING SHOWED GOOD INSTRUMENT PRECISION ON THE DAY OF TESTING AS WELL AS OVER TIME. NO OTHER INDICATION OF INSTRUMENT ISSUES WERE IDENTIFIED IN THE DATA FILES. NO PRODUCT NONCONFORMANCE HAS BEEN IDENTIFIED. THE CUSTOMER WAS PROVIDED INFORMATION REGARDING BIOTIN INTERFERENCE IN CERTAIN IMMUNOASSAYS. THE DEVICE IS OPERATING WITHIN SPECIFICATIONS. NO FURTHER INVESTIGATION IS REQUIRED.

Description of Event or Problem

A DISCORDANT, FALSELY ELEVATED FREE THYROXINE (FT4) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON THE DIMENSION VISTA 500 SYSTEM. THE RESULT WAS REPORTED TO THE PHYSICIAN(S) WHO QUESTIONED THE RESULT. THE SAME SAMPLE WAS PROCESSED ON AN ALTERNATE NON-SIEMENS INSTRUMENT OBTAINING A LOWER RESULT. THE CUSTOMER STATED THAT THE PATIENT'S SCHEDULED DILATION AND CURETTAGE SURGERY WAS DELAYED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED FT4 RESULT OR THE DELAY OF THE SURGERY.