DIMENSION®

Additional Manufacturer Narrative

MDR 2517506-2018-00260 WAS ALSO FILED FOR THE SAME AMY EVENT. THE CUSTOMER CONTACTED SIEMENS CUSTOMER CARE CENTER (CCC) AND REPORTED THAT A DISCORDANT, FALSELY ELEVATED AMYLASE (AMY) PATIENT RESULT WAS OBTAINED ON THE DIMENSION RXL MAX HM SYSTEM. SIEMENS IS INVESTIGATING THE INCIDENT.

Description of Event or Problem

A DISCORDANT, FALSELY ELEVATED AMYLASE (AMY) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON THE DIMENSION RXL MAX HM SYSTEM. THE RESULT WAS REPORTED TO THE PHYSICIAN WHO QUESTIONED THE RESULT. THE SAME SAMPLE WAS TESTED ON THE SAME INSTRUMENT AT A LATER DATE AND AN ELEVATED RESULT WAS OBTAINED. THE PATIENT WAS HOSPITALIZED FOR SUSPECTED PANCREATITIS. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ELEVATED AMY RESULT.

Additional Manufacturer Narrative

ORIGINAL MDR(B)(6) 2018. (ADDITIONAL INFORMATION 21-MAY-2018) SIEMENS HEADQUARTERS SUPPORT CENTER (HSC) EVALUATED INSTRUMENT DATA LOGS AND THE AVAILABLE INFORMATION. THE CUSTOMER CONFIRMED THAT NO MEDICAL PROCEDURE WAS PERFORMED ON THE PATIENT NOR TREATMENT MODIFIED BASED UPON THE DISCORDANT ELEVATED AMYLASE (AMY) RESULT. INSTRUMENT DAILY SYSTEM CHECKS DISPLAYED NO ATYPICAL PERFORMANCE. AMY CALIBRATION DATA WAS WITHIN CONFORMANCE AT THE TIME OF THE EVENT. QUALITY CONTROL RESULTS WERE REPORTED AS RECOVERING WITHIN THE CUSTOMER ESTABLISHED RANGES. A CUSTOMER SERVICE ENGINEER WAS DISPATCHED TO THE SITE AND DID NOT IDENTIFY ANY INSTRUMENT MALFUNCTIONS. HSC CONCLUDED THAT NO PRODUCT NON-CONFORMANCE WAS IDENTIFIED. THE CAUSE IS UNKNOWN. THE DEVICE IS OPERATING WITHIN SPECIFICATIONS. NO FURTHER INVESTIGATION IS REQUIRED. SECTION H6 HAS BEEN UPDATED TO REFLECT THE HSC CONCLUSION.