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

Additional Manufacturer Narrative

SIEMENS FILED THE INITIAL MDR ON 20-AUG-2019. ADDITIONAL INFORMATION (23-AUG-2019): SIEMENS FURTHER INVESTIGATED THE ISSUE. BASED ON THE ANALYSIS OF THE BN II SYSTEM FILES, A GENERAL PRODUCT PROBLEM COULD BE EXCLUDED. THE RESULT DIFFERENCES WERE LIMITED TO TWO SINGLE PATIENT SAMPLE RESULTS. A SAMPLE CHARACTERISTIC INFLUENCE COULD NOT BE EXCLUDED, AS BOTH AFFECTED SAMPLES WERE OBTAINED FROM MULTIPLE MYELOMA PATIENTS. AS PER THE N ANTISERUM TO HUMAN-IG/L-CHAIN INSTRUCTIONS FOR USE (IFU), "THE NEPHELOMETRIC DETERMINATION OF HUMAN IMMUNOGLOBULIN/L-CHAINS, TYPES KAPPA AND LAMBDA, CANNOT REPLACE IMMUNOELECTROPHORESIS OR IMMUNOFIXATION ELECTROPHORESIS IN THE DIAGNOSIS OF MONOCLONAL GAMMOPATHY." RESULTS OF THIS TEST SHOULD ALWAYS BE INTERPRETED IN CONJUNCTION WITH THE PATIENT'S MEDICAL HISTORY, CLINICAL PRESENTATION AND OTHER FINDINGS. THE CAUSE OF THE EVENT IS UNKNOWN. THE REAGENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

Additional Manufacturer Narrative

THE CUSTOMER CONTACTED A SIEMENS CUSTOMER CARE CENTER (CCC) AND REPORTED THAT TWO DISCORDANT, FALSELY LOW IG/L-CHAIN, TYPE KAPPA RESULTS WERE OBTAINED ON TWO PATIENT SERUM SAMPLES ON A BN II SYSTEM USING N ANTISERUM TO HUMAN-IG/L-CHAIN, TYPE KAPPA REAGENT. QUALITY CONTROLS (QC) RECOVERED WITHIN RANGE ON THE DAY THE DISCORDANT RESULTS WERE OBTAINED. THE CUSTOMER SENT SIEMENS THE BN II SYSTEM LOG FILES FOR FURTHER INVESTIGATION. SIEMENS IS INVESTIGATING THE ISSUE.

Description of Event or Problem

TWO DISCORDANT, FALSELY LOW IG/L-CHAIN, TYPE KAPPA RESULTS WERE OBTAINED ON TWO PATIENT SERUM SAMPLES ON A BN II SYSTEM USING N ANTISERUM TO HUMAN-IG/L-CHAIN, TYPE KAPPA REAGENT. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S), AND THE RESULTS WERE QUESTIONED BY THE PHYSICIAN(S). EACH OF THE TWO SAMPLES WAS REPEATED FOR IG/L-CHAIN, TYPE KAPPA IN A 1:100 DILUTION USING THE SAME SYSTEM AND REAGENT, RESULTING HIGHER. THE REPEAT RESULTS WERE REPORTED, AS THE CORRECT RESULTS, TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY LOW IG/L-CHAIN, TYPE KAPPA RESULTS.