N LATEX FLC KAPPA

Description of Event or Problem

THE CUSTOMER REPORTED THE OBSERVATION OF DISCORDANT FLC KAPPA (FLC_K) RESULTS OBTAINED ON ONE PATIENT SAMPLE MEASURED WITH N LATEX FLC KAPPA LOT 473199 ON THE ATELLICA NEPH 630 SYSTEM. IT IS UNKNOWN WHICH FLC KAPPA RESULT WAS CONSIDERED CORRECT. IT IS UNKNOWN WHICH FLC KAPPA RESULT WAS REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT RESULTS.

Additional Manufacturer Narrative

AN OUTSIDE OF THE UNITED STATES (OUS) CUSTOMER CONTACTED A SIEMENS REGIONAL SUPPORT CENTER TO REPORT THE OBSERVATION OF DISCORDANT FLC KAPPA (FLC_K) RESULTS OBTAINED ON ONE PATIENT SAMPLE MEASURED WITH N LATEX FLC KAPPA LOT 473199 ON THE ATELLICA NEPH 630 SYSTEM. BASED ON THE PREVIOUS VALUES FROM THE PATIENT, SAMPLE (B)(6), WHICH WAS MEASURED ON (B)(6) 2025, WAS REPEATED THE FOLLOWING DAY. THE FOLLOWING CONCLUSION IS MADE FROM THE TROUBLESHOOTING PERFORMED BY SIEMENS HEALTHINEERS: BASED ON THE PROVIDED DATA AND INFORMATION THE PROBABLE CAUSE OF THE DISCORDANT FLC KAPPA PATIENT SAMPLE RESULTS COULD NOT BE IDENTIFIED. NO OTHER DISCORDANT RESULTS WERE OBTAINED; NO INSTRUMENT FLAGS HAVE BEEN IDENTIFIED. CALIBRATION CURVE SHOWED NO ISSUES. ONE SINGLE CONTROL RESULT MEASURED ON (B)(6) 2025 WAS FOUND OUT OF TAV RANGE, ALL FURTHER RESULTS WERE FOUND WITHIN RANGE. QC WAS IN RANGE AT THE TIMES THE SAMPLE WAS RUN. THE KINETIC CURVES FOR THE AFFECTED SAMPLE MEASUREMENTS DO NOT SHOW ANY ABNORMALITIES. REAGENTS ARE FUNCTIONING PROPERLY. ULTIMATELY, NO DEFICIENCIES IN TEST PERFORMANCE WERE IDENTIFIED. THE CAUSE OF THE DISCREPANT RESULTS CANNOT BE FINALLY IDENTIFIED. THE CUSTOMER IS OPERATIONAL. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED. 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