BN II SYSTEM

Additional Manufacturer Narrative

THE CUSTOMER CONTACTED A SIEMENS CUSTOMER CARE CENTER AND REPORTED THAT A DISCORDANT, FALSELY ELEVATED FREE LIGHT CHAINS (FLC), TYPE KAPPA (FLC KAPPA) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON THE BN II SYSTEM. SIEMENS INVESTIGATED THE DATA PROVIDED BY THE CUSTOMER AND DETERMINED THAT THE CALIBRATION CURVES ON BOTH SYSTEMS WERE ACCEPTABLE. THE QUALITY CONTROLS (QCS) ON BOTH SYSTEMS RECOVERED WITHIN ACCEPTABLE RANGES ON THE DAY OF THE EVENT. THERE IS NO INDICATION OF AN SYSTEM OR REAGENT MALFUNCTION AS THE ACCEPTABLE RESULTS WERE OBTAINED USING THE SAME REAGENT LOT AND SYSTEM. THE CUSTOMER DID NOT PROVIDE THE SYSTEM FILES FOR FURTHER INVESTIGATION AND THE CAUSE OF THE DISCORDANT, FALSELY ELEVATED FLC KAPPA RESULT IS UNKNOWN. THE SYSTEM IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

Description of Event or Problem

A DISCORDANT, FALSELY ELEVATED FREE LIGHT CHAINS (FLC), TYPE KAPPA (FLC KAPPA) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A BN II SYSTEM. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULT. ON THE NEXT DAY, THE SAMPLE WAS REPEATED ON THE SAME SYSTEM, RESULTING LOWER. THE REPEAT RESULT WAS REPORTED, AS THE CORRECT RESULT, TO THE PHYSICIAN(S). ON (B)(6) 2018, THE SAMPLE WAS REPEATED ON THE SAME SYSTEM AND AT AN ALTERNATE LABORATORY. THE 2ND REPEAT RESULTS AND THE RESULTS OBTAINED AT THE ALTERNATE LABORATORY CORRELATED WITH THE REPEAT RESULT OBTAINED ON (B)(6) 2018. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED FLC KAPPA RESULT.