N LATEX FLC KAPPA

Additional Manufacturer Narrative

AN OUTSIDE OF THE UNITED STATES (OUS) CUSTOMER CONTACTED THE SIEMENS CUSTOMER CARE CENTER (CCC) TO REPORT FALSELY DEPRESSED N LATEX FLC KAPPA RESULTS ON AN ATELLICA NEPH 630 INSTRUMENT. QUALITY CONTROLS (QCS) RECOVERED WITHIN RANGES AT THE TIME OF THE EVENT. 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 DEPRESSED N LATEX FLC KAPPA RESULT ON AN ATELLICA NEPH 630 INSTRUMENT. THE SAMPLE WAS REPEATED FOR TROUBLESHOOTING PURPOSES WITH THE N LATEX FLC KAPPA REAGENT ON THE SAME INSTRUMENT. THE REPEAT RESULT WAS ALSO ELEVATED AND CONSIDERED ERRONEOUS AND THEREFORE NOT REPORTED. THE SAMPLE WAS REPEATED WITH AN ALTERNATE REAGENT ON THE SAME INSTRUMENT AND THIS RESULT WAS LOWER THAN THE ERRONEOUS RESULTS AND ALIGNED WITH THE ELECTROPHORESIS IMMUNOFIXATION RESULTS. THE REPEAT RESULT WITH THE ALTERNATE REAGENT WAS REPORTED, AS THE CORRECT RESULT, TO THE PHYSICIAN(S). THERE IS NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY DEPRESSED N LATEX FLC KAPPA RESULTS.

Additional Manufacturer Narrative

SIEMENS FILED THE INITIAL MDR ON 24-SEP-2024. MDR 9610806-2024-00038 WAS FILED FOR DISCORDANT RESULTS WITH ANOTHER ANALYTE (N LATEX FLC LAMBDA) WITH THE SAME PATIENT SAMPLE. ADDITIONAL INFORMATION 26-SEP-2024: SIEMENS INVESTIGATION HAS CONCLUDED. BASED ON A REVIEW OF THE AVAILABLE INFORMATION, THE PROBABLE CAUSE OF DISCORDANT N LATEX FLC KAPPA RESULTS ON THE ATELLICA NEPH 630 COMPARED TO AN ALTERNATE REAGENT ON THE SAME INSTRUMENT AND ELECTROPHORESIS IMMUNOFIXATION COULD NOT BE IDENTIFIED. NO OTHER DISCORDANT RESULTS WERE OBTAINED FOR N LATEX FLC KAPPA, AND CALIBRATION AS WELL AS QUALITY CONTROL (QC) DATA WERE VALID. THESE OBSERVATIONS SUGGEST A SINGLE EVENT FOR ONE SINGLE PATIENT SAMPLE RESULT. INFORMATION PROVIDED IN THE REPORT FROM THE CUSTOMER INDICATES THE AFFECTED SAMPLE WAS COLLECTED ON 31-JUL-2024 AND STORED FOR 13 DAYS AT 2 TO 8 °C BEFORE TESTING THE SAMPLE FOR THE FIRST TIME ON 12-AUG-2024. THE GUIDANCE FOR SAMPLE COLLECTION AND HANDLING PROVIDED IN THE N LATEX FLC KAPPA IFU STATES THAT SAMPLES SHOULD BE STORED FOR NO MORE THAN 5 DAYS AT 2 TO 8 °C. THE CUSTOMER'S SAMPLE HANDLING VIOLATES THE GUIDANCE IN THE IFU. NO ASSAY PERFORMANCE ISSUE COULD BE IDENTIFIED. THE PROBABLE CAUSE OF THE DISCORDANT RESULTS IS CONSISTENT WITH A SAMPLE INTEGRITY ISSUE POSSIBLY CAUSED BY INAPPROPRIATE SAMPLE HANDLING; HOWEVER, THE ROOT CAUSE CANNOT BE CLARIFIED DUE TO LACK OF INFORMATION TO PROVE THE SAMPLE HANDLING WAS THE CAUSE OF THE ISSUE. THE CUSTOMER IS OPERATIONAL. THE N LATEX FLC KAPPA LOT 473183 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.