N LATEX FLC LAMBDA

Description of Event or Problem

THE CUSTOMER REPORTED THE OBSERVATION OF DISCORDANT ELEVATED FLC LAMBDA (FLC_L) RESULT OBTAINED ON ONE PATIENT SAMPLE COMPARED TO REPEAT TESTING MEASURED WITH N LATEX FLC LAMBDA LOT 473210A ON THE BN II SYSTEM. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT RESULT.

Additional Manufacturer Narrative

AN OUTSIDE OF THE UNITED STATES (OUS) CUSTOMER CONTACTED A SIEMENS REGIONAL SUPPORT CENTER TO REPORT THE OBSERVATION OF DISCORDANT ELEVATED FLC LAMBDA (FLC_L) RESULT OBTAINED ON ONE PATIENT SAMPLE COMPARED TO REPEAT TESTING MEASURED WITH N LATEX FLC LAMBDA LOT 473210A ON THE BN II SYSTEM. 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.

Additional Manufacturer Narrative

AN OUTSIDE OF THE UNITED STATES (OUS) CUSTOMER CONTACTED A SIEMENS REGIONAL SUPPORT CENTER TO REPORT THE OBSERVATION OF DISCORDANT ELEVATED FLC LAMBDA (FLC_L) RESULT OBTAINED ON ONE PATIENT SAMPLE COMPARED TO REPEAT TESTING MEASURED WITH N LATEX FLC LAMBDA LOT 473210A ON THE BN II SYSTEM. THE FOLLOWING CONCLUSION IS MADE FROM THE TROUBLESHOOTING PERFORMED BY SIEMENS HEALTHINEERS: BASED ON THE REVIEW OF INFORMATION PROVIDED, THE PROBABLE CAUSE OF THE DISCORDANT ELEVATED FLC LAMBDA (FLC_L) RESULT COULD NOT BE FINALLY IDENTIFIED. THE AVAILABLE KINETIC CURVES OF THE INDIVIDUAL MEASUREMENTS FROM VARIOUS SAMPLES SHOW NO ABNORMALITIES. BASED ON THE CURRENT DATA SITUATION, NO CLEAR CAUSE FOR THE DISCORDANT RESULTS CAN BE IDENTIFIED. A REVIEW OF THE PAST TWO YEARS OF HISTORY SHOWS NO ADDITIONAL COMPLAINT REGARDING DISCORDANT RESULTS FOR AFFECTED N LATEX FLC LAMBDA LOT. A SAMPLE-SPECIFIC OR PRE-ANALYTICAL ISSUE CANNOT BE RULED OUT. ULTIMATELY, NO DEFICIENCIES IN TEST PERFORMANCE WERE IDENTIFIED. THE CAUSE OF THE DISCREPANT RESULTS CANNOT BE FINALLY IDENTIFIED. HOWEVER, A SAMPLE-SPECIFIC OR PRE-ANALYTICAL ISSUE CANNOT BE COMPLETELY RULED OUT. 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.