BN II SYSTEM

Description of Event or Problem

THE CUSTOMER CONTACTED SIEMENS AND REPORTED THAT FALSELY ELEVATED OR DEPRESSED FREE LIGHT CHAINS TYPE KAPPA (FLC KAPPA) RESULTS WERE OBTAINED ON MULTIPLE PATIENT SAMPLES ON A BNII SYSTEM USING N LATEX FLC KAPPA REAGENT. THE INITIAL AND REPEAT RESULTS WERE NOT REPORTED EXCEPT FOR TWO PATIENT SAMPLES. OTHER PATIENT SAMPLES WERE NOT REPORTED DUE TO UNCERTAINTY ABOUT WHICH RESULT SHOULD BE CONSIDERED CORRECT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY ELEVATED OR DEPRESSED FLC KAPPA RESULTS.

Additional Manufacturer Narrative

AN OUTSIDE UNITED STATES (OUS) CUSTOMER CONTACTED A SIEMENS CUSTOMER CARE CENTER TO REPORT INCONSISTENT N LATEX FLC KAPPA RESULTS THAT WERE OBTAINED ON MULTIPLE PATIENT SAMPLES ON A BN II INSTRUMENT. QUALITY CONTROLS (QCS) RECOVERED WITHIN RANGES ON THE DAY OF THE EVENT.