ATELLICA NEPH 630 SYSTEM

Description of Event or Problem

A DISCORDANT, FALSELY LOW KAPPA LIGHT CHAINS RESULT AND A DISCORDANT, FALSELY ELEVATED LAMBDA LIGHT CHAINS RESULT WERE OBTAINED ON A PATIENT SAMPLE ON AN ATELLICA NEPH 630 SYSTEM. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S). TWO DAYS LATER, THE SAMPLE WAS REPEATED FOR KAPPA LIGHT CHAINS AND LAMBDA LIGHT CHAINS. THE KAPPA LIGHT CHAINS RESULT RECOVERED HIGHER AND THE LAMBDA LIGHT CHAINS RESULT RECOVERED LOWER. THE REPEAT RESULTS WERE REPORTED, AS THE CORRECT RESULTS, TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT KAPPA LIGHT CHAINS AND LAMBDA LIGHT CHAINS RESULTS.

Additional Manufacturer Narrative

AN OUTSIDE OF THE UNITED STATES (OUS) CUSTOMER CONTACTED A SIEMENS CUSTOMER CARE CENTER (CCC). QUALITY CONTROLS (QC) HAD RECOVERED OUT OF RANGE AT THE TIME OF THE EVENT. A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) DETERMINED THAT A SYSTEM WASTE PUMP HAD FAILED, AND THE CSE REPLACED THE PUMP. THE WASTE PUMP HAD BEEN INSTALLED IN FEBRUARY OF 2021 AND WAS OVER THE EXPECTED LIFETIME OF THIS PART OF ONE YEAR. THE SYSTEM WAS RETURNED TO NORMAL OPERATION AFTER THE WASTE PUMP WAS REPLACED. HOWEVER, NO RELATIONSHIP BETWEEN THE FAILED WASTE PUMP AND THE DISCORDANT PATIENT SAMPLE RESULTS COULD BE IDENTIFIED. THE CAUSE OF THE DISCORDANT RESULTS IS UNKNOWN. THE SYSTEM IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED. THE ATELLICA NEPH 630 SYSTEM IS NOT MARKETED IN THE UNITED STATES (US). THIS MDR IS FILED FOR THE US SIMILAR SYSTEM (BN PROSPEC SYSTEM). THE BN PROSPEC SYSTEM MARKETED IN THE US HAS CATALOG NUMBER 10461865, UNIQUE DEVICE IDENTIFIER (B)(6) AND THE PMA/510(K) K001647.