N LATEX FLC KAPPA

Additional Manufacturer Narrative

AN OUTSIDE OF THE UNITED STATES (OUS) CUSTOMER CONTACTED THE SIEMENS CUSTOMER CARE CENTER (CCC) TO REPORT A FALSELY DEPRESSED N LATEX FLC KAPPA RESULT ON A BN II SYSTEM. QUALITY CONTROLS (QCS) RECOVERED WITHIN RANGES AT THE TIME OF THE EVENT. 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 10873629. THE 510(K) NUMBER DOCUMENTED IN SECTION G4 IS FOR THE US PRODUCT.

Description of Event or Problem

THE CUSTOMER REPORTED THE OBSERVATION OF A FALSELY DEPRESSED N LATEX FLC KAPPA RESULT ON A BN II SYSTEM. THE ERRONEOUS RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULT. THE SAMPLE WAS REPEATED ON THE SAME INSTRUMENT, AND THE REPEAT RESULT WAS ALSO DEPRESSED. THE SAMPLE WAS THEN ANALYZED WITH AN IMMUNOFIXATION ELECTROPHORESIS METHOD AND THE RESULT FOR KAPPA WAS POSITIVE WHICH WAS ACCEPTED BY THE PHYSICIAN, AS THIS RESULTS IS AGREEMENT WITH CLINICAL PICTURE FOR THIS PATIENT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY DEPRESSED N LATEX FLC KAPPA RESULT.

Additional Manufacturer Narrative

SIEMENS FILED THE INITIAL MDR 9610806-2024-00049 ON 18-NOV-2024. ADDITIONAL INFORMATION 16-DEC-2024: AS PART OF THE TECHNICAL EVALUATION, SIEMENS REQUESTED THE BN II SYSTEM TROUBLESHOOTING FILE AND MORE DETAILED INFORMATION IN ORDER TO PERFORM A DETAILED ANALYSIS AND IDENTIFY THE POTENTIAL CAUSE FOR THE DISCORDANT PATIENT RESULTS VERSUS AN ALTERNATE METHOD. NO TROUBLESHOOTING FILE COULD BE PROVIDED CONTAINING THE AFFECTED PATIENT SAMPLE RESULT DATA. NO FURTHER INFORMATION WAS PROVIDED. BASED UPON THE LIMITED INFORMATION RECEIVED, FURTHER EVALUATION IS NOT POSSIBLE. THE CUSTOMER IS OPERATIONAL. THE N LATEX FLC KAPPA LOT 473183 IS PERFORMING AS INTENDED. A PRODUCT PERFORMANCE ISSUE HAS NOT BEEN IDENTIFIED. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED. IN SECTION H6, THE INVESTIGATION FINDINGS AND INVESTIGATION CONCLUSIONS CODES WERE UPDATED.