N LATEX FLC KAPPA

Additional Manufacturer Narrative

AN OUTSIDE OF THE UNITED STATES (OUS) CUSTOMER CONTACTED A SIEMENS REGIONAL SUPPORT CENTER TO REPORT THE OBSERVATION OF INCONSISTENT AND DISCORDANT FLC KAPPA (FLC_K) RESULTS OBTAINED ON ONE PATIENT SAMPLE MEASURED WITH N LATEX FLC KAPPA LOT 473197A ON THE ATELLICA NEPH 630 SYSTEM COMPARED TO REPEAT TESTING USING AN ALTERNATE METHOD. BASED ON THE REVIEW OF INFORMATION PROVIDED, THE PROBABLE CAUSE OF INCONSISTENT FLC KAPPA PATIENT SAMPLE RESULTS COULD NOT BE FINALLY IDENTIFIED. THE CALIBRATION AND QC PERFORMANCE WAS VALID ON THE DATES OF TESTING ON THE ATELLICA NEPH 630 SYSTEM. BASED ON SAVE DATA FILE ANALYSIS, ALL SAMPLE RESULTS > 106 MG/L ABOVE MEASURING RANGE OBTAINED IN 1:100 DILUTION WERE FLAGGED WITH PRE-REACTION ERRORS ON THE ATELLICA NEPH 630 SYSTEM. A REVIEW OF HISTORY SHOWS NO ADDITIONAL COMPLAINTS REGARDING DISCORDANT RESULTS FOR AFFECTED N LATEX FLC KAPPA LOT. ULTIMATELY, NO DEFICIENCIES IN TEST PERFORMANCE WERE IDENTIFIED. THE CAUSE OF THE DISCREPANT RESULTS CANNOT BE FINALLY IDENTIFIED. HOWEVER, ALL OBSERVATIONS INDICATE THE PROBABLE CAUSE OF THE DISCORDANT FLC KAPPA RESULTS FOR ONE SINGLE PATIENT IS CONSISTENT WITH A SAMPLE INTEGRITY EFFECT. THE CUSTOMER IS OPERATIONAL. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED. SECTION H6 HAS BEEN UPDATED TO REFLECT UPDATED INVESTIGATION FINDINGS AND INVESTIGATION CONCLUSION CODES.

Additional Manufacturer Narrative

AN OUTSIDE OF THE UNITED STATES (OUS) CUSTOMER CONTACTED A SIEMENS REGIONAL SUPPORT CENTER TO REPORT THE OBSERVATION OF INCONSISTENT AND DISCORDANT FLC KAPPA RESULTS ON AN ATELLICA NEPH 630 INSTRUMENT. CUSTOMER TESTED ANOTHER SAMPLE FROM THE SAME PATIENT AND SAW SIMILAR RESULTS (RESULTS AND DATE OF TESTING NOT PROVIDED). IN ADDITION, THE CUSTOMER TESTED THE SAMPLE WITH A HETEROPHILIC BINDING TUBE AND OBSERVED SIMILAR RESULTS (RESULTS AND DATE OF TESTING NOT PROVIDED). 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 INCONSISTENT AND DISCORDANT FLC KAPPA (FLC_K) RESULTS OBTAINED ON ONE PATIENT SAMPLE MEASURED WITH N LATEX FLC KAPPA LOT 473197A ON THE ATELLICA NEPH 630 SYSTEM COMPARED TO REPEAT TESTING USING AN ALTERNATE METHOD. THE RESULT OF THE ALTERNATE METHOD WAS REPORTED, AS THE CORRECT RESULT, TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THESE DISCORDANT RESULTS.