N ANTISERUM TO HUMAN-IG/L-CHAIN, K TYPE

Description of Event or Problem

THE CUSTOMER REPORTED THE OBSERVATION OF A FALSELY DEPRESSED KAPPA RESULT OBTAINED ON ONE PATIENT SERUM SAMPLE MEASURED WITH N ANTISERUM TO HUMAN IG/L-CHAIN, TYPE LOT: 122119 ON THE BNII SYSTEM. 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 A DISCORDANT KAPPA SERUM SAMPLE RESULT ON A BNII INSTRUMENT. QUALITY CONTROL RESULTS WERE WITHIN ACCEPTABLE RANGES ON THE DAY OF TESTING. PER THE INTENDED USE SECTION OF THE N ANTISERUM TO HUMAN-IG/L-CHAIN, K TYPE INSTRUCTIONS FOR USE (IFU): "RESULTS OF THE KAPPA MEASUREMENT SHOULD ALWAYS BE INTERPRETED IN CONJUNCTION WITH OTHER LABORATORY FINDINGS." SIEMENS IS INVESTIGATING. NOTE: THE N ANTISERUM TO HUMAN-IG/L-CHAIN, K TYPE REAGENT IS MARKETED IN THE UNITED STATES UNDER SIEMENS MATERIAL NUMBER: 10446595. THE 510(K) NUMBER DOCUMENTED IN SECTION G4 IS FOR THE US PRODUCT.

Additional Manufacturer Narrative

SIEMENS FILED THE INITIAL MDR ON 25-JUN-2025. ADDITIONAL INFORMATION 16-JUL-2025: SIEMENS REVIEWED THE INFORMATION PROVIDED AND DATA OBTAINED. BASED ON THE DATA ANALYSIS, THERE WAS NO INDICATION OF A SYSTEM RELATED ISSUE. BASED ON THE REVIEW OF INFORMATION PROVIDED, THE PROBABLE CAUSE OF THE DISCORDANT KAPPA RESULT FOR ONE PATIENT SAMPLE TESTED WITH N ANTISERUM TO HUMAN IG/L-CHAIN, TYPE LOT: 122119 ON THE BN II COULD NOT BE IDENTIFIED. NO OTHER DISCORDANT RESULTS WERE OBTAINED FOR METHOD KAPPA WITH OTHER PATIENTS. CALIBRATION DATA WAS ACCEPTABLE. THE QC PERFORMANCE COULD NOT BE EVALUATED DUE TO THE LACK OF DATA. THE INFORMATION PROVIDED INDICATES A SAMPLE SPECIFIC OBSERVATION FOR ONE SINGLE PATIENT SAMPLE. NO GENERAL PERFORMANCE ISSUE FOR METHOD KAPPA WAS IDENTIFIED THROUGH THE DATA ANALYSIS. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED. IN SECTION H6, THE INVESTIGATION FINDINGS AND INVESTIGATION CONCLUSIONS CODES WERE UPDATED.