N LATEX FLC KAPPA

Additional Manufacturer Narrative

SIEMENS FILED THE INITIAL MDR 9610806-2024-00022 ON 05-AUG-2024. SIEMENS FILED SUPPLEMENTAL MDR 9610806-2024-00022-S1 ON 26-AUG-2024. ADDITIONAL INFORMATION 02-OCT-2024: SIEMENS REVIEWED THE INFORMATION PROVIDED AND TROUBLESHOOTING FILE DATA OBTAINED VIA SMART REMOTE SERVICES (SRS). 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). THESE OBSERVATIONS SUGGESTED A SAMPLE INTERFERENT MAY HAVE CONTRIBUTED TO THE NON-REPRODUCIBLE RESULTS. SIEMENS REQUESTED THE AFFECTED SAMPLE TO BE SENT TO SIEMENS FOR FURTHER ANALYSIS. HOWEVER, INSUFFICIENT SAMPLE WAS AVAILABLE AT THE CUSTOMER SITE TO SENT. THEREFORE, SIEMENS PERFORM TESTING WITH INTERNAL SAMPLES TO EVALUATE THE FLC KAPPA ASSAY PERFORMANCE WITH N LATEX FLC KAPPA LOT 473182 ON THE ATELLICA CH 930 WITH THE FOLLOWING OUTCOME: N LATEX FLC KAPPA LOT 473182 WAS CALIBRATED WITH N FLC STANDARD SL LOT 473475 ON THE ATELLICA CH 930. THE SYSTEM PERFORMANCE WAS VERIFIED WITH N FLC CONTROL SL1 LOT 473579 AND N FLC CONTROL SL2 LOT 473679 IN REPLICATES OF 2. THREE SERUM SAMPLES CONTAINING A FLC KAPPA CONCENTRATION WITHIN AND HIGHER THAN THE UPPER LIMIT OF REFERENCE INTERVAL FOR N LATEX FLC KAPPA WERE TESTED, NATIVE AND 1:10 MANUALLY DILUTED WITH ATELLICA CH DILUENT EACH IN REPLICATES OF TWO. THE REFERENCE CURVE ESTABLISHED WAS VALID. THE VALUES FOR N FLC CONTROL SL1 LOT 473579 AND N FLC CONTROL SL2 LOT 473679 RECOVERED WITHIN THE ASSIGNED RANGES AS SPECIFIED BY THE TAV´S. ASSAY AND SYSTEM PERFORMED AS INTENDED WHEN TESTING THREE SERUM SAMPLES CONTAINING A FLC KAPPA CONCENTRATION WITHIN AND HIGHER THAN THE UPPER LIMIT OF REFERENCE INTERVAL FOR N LATEX FLC KAPPA. BASED ON THE ANALYSIS, TROUBLESHOOTING ACTIONS AND SYSTEM VERIFICATION INDICATE ACCEPTABLE PERFORMANCE. ALL CLAIMS/SPECIFICATIONS WERE MET BASED ON THE INTERNAL TESTING AND NO PRODUCT PROBLEM COULD BE IDENTIFIED. THE CUSTOMER IS OPERATIONAL. N LATEX FLC KAPPA LOT 473182A 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.

Additional Manufacturer Narrative

SIEMENS FILED THE INITIAL MDR 9610806-2024-00022 ON 05-AUG-2024. CORRECTED INFORMATION: SECTION A2 HAS BEEN UPDATED TO REFLECTED CORRECTED INFORMATION ABOUT THE PATIENT AGE. THE AGE OF THE PATIENT WAS INCORRECTLY LISTED AS 60 IN THE INITIAL MDR AND THE PATIENT IS ACTUALLY 73 YEARS OLD. SIEMENS CONTINUES TO INVESTIGATE.

Additional Manufacturer Narrative

AN OUTSIDE OF THE UNITED STATES (OUS) CUSTOMER CONTACTED THE SIEMENS CUSTOMER CARE CENTER (CCC) TO REPORT A FALSELY ELEVATED N LATEX FLC KAPPA RESULT ON AN ATELLICA CH 930 ANALYZER. 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 ELEVATED N LATEX FLC KAPPA RESULT ON AN ATELLICA CH 930 ANALYZER. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULT. THE SAMPLE WAS REPEATED USING BOTH MANUAL AND AUTOMATIC DILUTION. THE REPEAT RESULTS WERE LOWER THAN THE INITIAL RESULT. THE REPEAT RESULTS WERE BELOW THE MEASURING INTERVAL, AND THE BELOW MEASURING INTERVAL RESULT WAS REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY ELEVATED N LATEX FLC KAPPA RESULT.