BN II SYSTEM

Description of Event or Problem

THE CUSTOMER REPORTED THAT FALSELY ELEVATED FREE LIGHT CHAINS, TYPE KAPPA, (FLC KAPPA) RESULTS WERE OBTAINED ON A PATIENT SAMPLE USING A 1:1000 AND 1:400 DILUTION ON A BN II INSTRUMENT. THE FALSELY ELEVATED RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED USING A 1:100 DILUTION AND THE RESULT WAS LOWER. THE LOWER RESULT WAS REPORTED AS THE CORRECT RESULT TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY ELEVATED FLC KAPPA RESULTS.

Additional Manufacturer Narrative

AN OUTSIDE OF THE UNITED STATES (OUS) CUSTOMER CONTACTED A SIEMENS REMOTE SUPPORT CENTER TO REPORT FALSELY ELEVATED FREE LIGHT CHAIN, TYPE KAPPA (FLC KAPPA), PATIENT RESULTS THAT WERE OBTAINED ON A BN II INSTRUMENT USING N LATEX FLC KAPPA REAGENT. SIEMENS EVALUATED THE ISSUE AND PROVIDED THE FOLLOWING CONCLUSION: A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) RESOLVED THE ISSUE BY DECONTAMINATING THE INSTRUMENT. THE CUSTOMER IS OPERATIONAL AND THE REPORTED ISSUE WAS RESOLVED BY ROUTINE SERVICE ACTIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.