ATELLICA CH TOTAL PROTEIN_2 (URINE) (UPRO)

Additional Manufacturer Narrative

THE CUSTOMER CONTACTED SIEMENS CUSTOMER CARE CENTER. SIEMENS HEADQUARTERS SUPPORT CENTER (HSC) REVIEWED THE INFORMATION PROVIDED BY THE CUSTOMER. HSC FOUND THAT ALL THE PROVIDED RESULTS (INCLUDING ATELLICA) ARE ALL ON THE LOWER SIDE OF THE ASSAY RANGE, AND AS PER THE INTERPRETATION OF RESULTS SECTION OF THE INSTRUCTIONS FOR USE (IFU) STATES: RESULTS OF THIS ASSAY SHOULD ALWAYS BE INTERPRETED IN CONJUNCTION WITH THE PATIENT'S MEDICAL HISTORY, CLINICAL PRESENTATION, AND OTHER FINDINGS. THE RESULT OF 0.05G/L IS BELOW THE ANALYTICAL MEASUREMENT RANGE AND ANALYTICAL SENSITIVITY OF THE EXL UCFP ASSAY AND THUS SHOULD BE REPORTED AS <0.06 G/L NOT 0.05 G/L. THE DIMENSION EXL AND ATELLICA CH 930 MODULE RESULTS EQUIVALENT SINCE THEY ARE BOTH BELOW THEIR RESPECTIVE ANALYTICAL MEASUREMENT RANGES. THE PATIENT DIAGNOSIS AND MEDICATION LIST WERE NOT PROVIDED AND COULD CONTRIBUTE TO DIFFERENT RESULTS WHEN BEING MEASURED BY DIFFERENT METHODOLOGIES AND ANALYZERS. THE SAMPLES IN QUESTION REPEAT AS <0.01 G/L, AND THEREFORE THE SYSTEM AND SAMPLE INTEGRITY WERE NOT SUSPECTED TO BE CAUSING THESE LOWER RESULTS. BOTH SAMPLES IN QUESTION WERE COLLECTED 3 DAYS BEFORE TESTING AND STORED REFRIGERATED PRIOR TO PROCESSING THE TESTING. PER THE IFU, SPECIMENS MAY BE STORED FOR UP TO 3 DAYS AT 4°C OR STORED FROZEN FOR UP TO 6 MONTHS AT -20°C FOR URINE AND CSF. THE SAMPLES IN QUESTION WERE ON THE EDGE OF THE ACCEPTABLE STORAGE OF THE SAMPLES. BASED ON THIS INFORMATION HSC CANNOT DEFINITIVELY IDENTIFY THE CAUSE OF THESE LOWER RESULTS ON THE UPRO ATELLICA AND EXL UCFP ASSAYS. METHODOLOGY AND DETECTION ARE DIFFERENT AND THEREFORE RESULTS MAY VARY BASED ON THE THIS. A SYSTEM OR PRODUCT NON-CONFORMANCE WAS NOT IDENTIFIED. THE CAUSE FOR THE DISCORDANT FALSELY DEPRESSED UPRO SAMPLES RESULTS IS UNKNOWN. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATION. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

Description of Event or Problem

TWO DISCORDANT, FALSELY DEPRESSED TOTAL PROTEIN_2 (URINE) (UPRO) RESULTS WERE OBTAINED USING ATELLICA CH 930 MODULE. THE INITIAL RESULTS WERE PERFORMED USING AN ALTERNATE NON-SIEMENS METHOD. THE INITIAL RESULTS WERE CONSIDERED CORRECT AND WERE REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE REPEATED USING SIEMENS ATELLICA CH 930 MODULE (BOTH SAMPLES) AND DIMENSION EXL (SAMPLE ID (B)(6) FOR TROUBLESHOOTING PURPOSE ONLY). THE REPEAT RESULTS FROM ATELLICA CH 930 MODULE WERE CONSIDERED DISCORDANT AND WERE NOT REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY DEPRESSED UPRO RESULTS.