N LATEX FLC KAPPA

Additional Manufacturer Narrative

SIEMENS FILED THE INITIAL MDR 9610806-2025-00011 ON 26-MAR-2025. SIEMENS FILED SUPPLEMENTAL MDR 9610806-2025-00011-S1 ON 16-APR-2025. ADDITIONAL INFORMATION ON 24-APR-2025: SIEMENS EVALUATED THIS ISSUE AND PROVIDED THE FOLLOWING CONCLUSION: THE ORIGINAL BEHAVIOR REPORTED BY THE CUSTOMER IS FALSELY DEPRESSED N LATEX FLC KAPPA AND N LATEX FLC LAMBDA RESULTS WHEN COMPARED TO INCREASED GAMMA GLOBULIN ELECTROPHORESIS RESULTS. THE SCREENSHOTS AND SAVE DATA FILES CONTAINED SOME CALIBRATION CURVES OF THE TESTS USED, ALL OF WHICH SHOWED NO ABNORMALITIES. NO QUALITY CONTROL (QC) DATA WAS PROVIDED. THE CUSTOMER IS RUNNING N LATEX FLC KAPPA WITH AN ADDITIONAL WASH. AS PER THE LIMITATIONS SECTION OF THE ASSAY¿S INSTRUCTIONS FOR USE, ¿USER DEFINED MODIFICATIONS ARE NOT SUPPORTED BY SIEMENS HEALTHINEERS AS THEY MAY AFFECT PERFORMANCE OF THE SYSTEM AND ASSAY RESULTS¿. BASED ON THE AVAILABLE INFORMATION, THERE IS NO EVIDENCE OF A REAGENT OR INSTRUMENT PROBLEM AND THE CAUSE OF THE DISCORDANT RESULTS IS INCONCLUSIVE. N LATEX FLC LAMBDA AND N LATEX FLC KAPPA ARE PERFORMING AS INTENDED. IN SECTION H6, THE INVESTIGATION FINDINGS AND CONCLUSION CODES WERE UPDATED. MDRS WERE SUBMITTED FOR THE RELATED EVENTS DOCUMENTED IN THE INITIAL MDR. SEE BELOW FOR DETAILS. FALSELY LOW N LATEX FLC LAMBDA RESULTS OBTAINED ON (B)(6) 2025: MDR 9610806-2025-00010. FALSELY LOW N LATEX FLC LAMBDA RESULTS OBTAINED ON (B)(6) 2025: MDR 9610806-2025-00012. FALSELY LOW N LATEX FLC KAPPA RESULTS OBTAINED ON (B)(6) 2025: MDR 9610806-2025-00013.

Description of Event or Problem

THE CUSTOMER OBSERVED FALSELY LOW N LATEX FLC KAPPA RESULTS FOR A PATIENT SAMPLE USING N LATEX FLC KAPPA LOT 473191 ON A BN II INSTRUMENT (SERIAL NUMBER: (B)(6) COMPARED TO INCREASED GAMMA GLOBULIN PROTEINS IN THE ELECTROPHORESIS. THE FALSELY LOW RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY LOW N LATEX FLC KAPPA RESULTS.

Additional Manufacturer Narrative

AN OUTSIDE THE UNITED STATES (OUS) CUSTOMER CONTACTED A SIEMENS REMOTE SUPPORT CENTER TO REPORT THE OBSERVATION OF FALSELY LOW N LATEX FLC KAPPA RESULTS OBTAINED ON A BN II INSTRUMENT. PER THE RESULTS SECTION OF THE N LATEX FLC KAPPA INSTRUCTIONS FOR USE (IFU): "RESULTS OF THIS TEST SHOULD ALWAYS BE INTERPRETED IN CONJUNCTION WITH THE PATIENT'S MEDICAL HISTORY, CLINICAL PRESENTATION AND OTHER 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.

Additional Manufacturer Narrative

SIEMENS FILED THE INITIAL MDR 9610806-2025-00011 ON 26-MAR-2025. ADDITIONAL INFORMATION 26-MAR-2025: MDRS WERE SUBMITTED FOR THE RELATED EVENTS DOCUMENTED IN THE INITIAL MDR. SEE BELOW FOR DETAILS. FALSELY LOW N LATEX FLC LAMBDA RESULTS OBTAINED (B)(6) 2025, MDR 9610806-2025-00010 SUBMITTED 26-MAR-2025. FALSELY LOW N LATEX FLC LAMBDA RESULTS OBTAINED (B)(6) 2025, MDR 9610806-2025-00012 SUBMITTED 26-MAR-2025. FALSELY LOW N LATEX FLC KAPPA RESULTS OBTAINED (B)(6) 2025, MDR 9610806-2025-00013 SUBMITTED 26-MAR-2025.