N LATEX FLC LAMBDA

Additional Manufacturer Narrative

AN OUTSIDE OF THE UNITED STATES (OUS) CUSTOMER CONTACTED A SIEMENS REGIONAL SUPPORT CENTER TO REPORT THE OBSERVATION OF DISCORDANT N LATEX FLC LAMBDA RESULTS ON A ATELLICA NEPH 630 INSTRUMENT. QUALITY CONTROL RESULTS WERE WITHIN ACCEPTABLE RANGES ON THE DAY OF TESTING. PER THE INTENDED USE SECTION OF THE N LATEX FLC LAMBDA INSTRUCTIONS FOR USE (IFU): "RESULTS OF THE FLC MEASUREMENT SHOULD ALWAYS BE INTERPRETED IN CONJUNCTION WITH OTHER LABORATORY FINDINGS." SIEMENS IS INVESTIGATING. NOTE: THE N LATEX FLC LAMBDA 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

Description of Event or Problem

THE CUSTOMER REPORTED THE OBSERVATION OF A FALSELY DEPRESSED FLC LAMBDA (FLC_L) RESULTS OBTAINED ON ONE PATIENT SAMPLE MEASURED WITH N LATEX FLC LAMBDA LOT 473295 ON THE ATELLICA NEPH 630 SYSTEM. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT RESULTS.

Additional Manufacturer Narrative

SIEMENS FILED THE INITIAL MDR 9610806-2025-00021 ON 13-JUN-2025. ADDITIONAL INFORMATION ON 30-JUN-2025: SIEMENS REVIEWED THE INFORMATION PROVIDED AND DATA OBTAINED. BASED ON THE DATA ANALYSIS, THERE WAS NO INDICATION OF A SYSTEM RELATED ISSUE. CALIBRATION WAS ACCEPTABLE AND QUALITY CONTROL REPLICATES RECOVERED WITHIN THE ASSIGNED RANGES AS SPECIFIED BY THE TABLES OF ASSIGNED VALUES (TAV´S). KINETICS AND DATA OF THE INITIAL TESTING ARE NOT AVAILABLE IN THE DATA SET. THE KINETICS OF THE REPEAT TESTS SHOW NO ABNORMALITIES. ACCORDING TO THE PROVIDED PATIENT INFORMATION, THE SAMPLE CONTAINS A HIGH IGA CONTENT. THIS COULD INDICATE A HIGH MONOCLONAL COMPONENT, WHICH MAY CAUSE A FALSELY LOW RESULT. THE INSTRUCTIONS FOR USE (IFU) DESCRIBE THIS PHENOMENON AS FOLLOWS: "EXCESSIVELY ELEVATED MONOCLONAL IMMUNOGLOBULIN CONCENTRATIONS MIGHT HAVE THE POTENTIAL TO SUPPRESS THE REACTION OF ANTI-FLC ANTIBODIES WITH FREE LIGHT CHAIN MOLECULES. IF RESULTS DO NOT FIT WITH PREVIOUS ONES, OR WITH RESULTS OF OTHER TESTS (E.G., SERUM IMMUNOELECTROPHORESIS, IMMUNOFIXATION, DIFFERENTIAL BLOOD CELL COUNT) AND/OR WITH THE CLINICAL SITUATION, IT IS RECOMMENDED TO REANALYZE THE SAMPLE IN A HIGHER SAMPLE DILUTION.". IN THIS SCENARIO, THE CUSTOMER REACTED CORRECTLY AND REMEASURED THE SAMPLE IN A HIGHER DILUTION. NO PRODUCT PROBLEM WAS IDENTIFIED AND THE CUSTOMER IS OPERATIONAL. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED. IN SECTION H6, THE INVESTIGATION FINDINGS AND INVESTIGATION CONCLUSIONS CODES WERE UPDATED.