N LATEX FLC KAPPA

Description of Event or Problem

THE CUSTOMER REPORTED THE OBSERVATION OF A FALSELY ELEVATED FLC KAPPA (FLC_K) RESULT OBTAINED ON ONE PATIENT SAMPLE MEASURED WITH N LATEX FLC KAPPA LOT 473196 ON THE BNII SYSTEM COMPARED TO REPEAT TESTING. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT RESULT.

Additional Manufacturer Narrative

AN OUTSIDE OF THE UNITED STATES (OUS) CUSTOMER CONTACTED A SIEMENS REGIONAL SUPPORT CENTER TO REPORT THE OBSERVATION OF ONE DISCORDANT HIGH FLC KAPPA RESULT ON A BNII INSTRUMENT. QUALITY CONTROL RESULTS WERE WITHIN ACCEPTABLE RANGES ON THE DAYS OF TESTING. PER THE INTENDED USE SECTION OF THE N LATEX FLC KAPPA INSTRUCTIONS FOR USE (IFU): " RESULTS OF FLC MEASUREMENTS SHOULD ALWAYS BE INTERPRETED IN CONJUNCTION WITH OTHER LABORATORY AND CLINICAL FINDINGS." SIEMENS IS INVESTIGATING. NOTE: THE N LATEX FLC KAPPA REAGENT IS MARKETED IN THE UNITED STATES UNDER SIEMENS MATERIAL NUMBER 10873630. THE 510(K) NUMBER DOCUMENTED IN SECTION G4 IS FOR THE US PRODUCT.

Additional Manufacturer Narrative

SIEMENS FILED THE INITIAL MDR 9610806-2025-00031 ON 29-JUL-2025. ADDITIONAL INFORMATION 28-AUG-2025: SIEMENS REVIEWED THE INFORMATION PROVIDED AND DATA OBTAINED. BASED ON THE REVIEW OF INFORMATION PROVIDED: CALIBRATION AND CONTROL DATA WERE ACCEPTABLE ON THE DAY OF EVENT. NO GENERAL PERFORMANCE ISSUE FOR METHOD FLC KAPPA WAS IDENTIFIED THROUGH THE DATA ANALYSIS. THE PROBABLE CAUSE OF THE DISCORDANT FLC KAPPA RESULT FOR ONE PATIENT SAMPLE TESTED WITH N LATEX FLC KAPPA LOT 473196 ON THE BN II SYSTEM COULD NOT BE IDENTIFIED BASED ON THE REVIEW OF THE DATA PROVIDED. IN SECTION H6, THE INVESTIGATION FINDINGS AND INVESTIGATION CONCLUSIONS CODES WERE UPDATED.