ADVIA CENTAUR PROSTATE-SPECIFIC ANTIGEN (PSA)

Additional Manufacturer Narrative

MDR 1219913-2024-00343 WAS INITIALLY FILED ON 06-JUN-2024. ADDITIONAL INFORMATION (27-JUN-2024): SIEMENS HEALTHCARE DIAGNOSTICS HAS CONCLUDED THE INVESTIGATION OF THE EVENT. A CUSTOMER FROM OUTSIDE THE UNITED STATES REPORTED OBSERVATION OF DEPRESSED ADVIA CENTAUR PSA RESULTS WHICH WERE DISCORDANT RELATIVE TO ALTERNATE METHOD TESTING WHILE USING LOT 336. SIEMENS EVALUATED THE INSTRUMENT DATA AND THE INFORMATION PROVIDED BY THE CUSTOMER. THE CALIBRATION WAS VALID AND QUALITY CONTROL (QC) WAS PERFORMING ACCEPTABLY. THE ASSAY'S INSTRUCTIONS FOR USE (IFU) PROVIDES THE FOLLOWING WARNING, UNDER INTENDED USE: "THE CONCENTRATION OF TOTAL PSA IN A GIVEN SPECIMEN, AS DETERMINED BY ASSAYS FROM DIFFERENT MANUFACTURERS, CAN VARY DUE TO DIFFERENCES IN ASSAY METHODS AND REAGENT SPECIFICITY. THE RESULTS REPORTED BY THE LABORATORY TO THE PHYSICIAN MUST INCLUDE THE IDENTITY OF THE ASSAY FOR TOTAL PSA USED. VALUES OBTAINED WITH DIFFERENT ASSAY METHODS CANNOT BE USED INTERCHANGEABLY. IF, IN THE COURSE OF MONITORING A PATIENT, THE ASSAY METHOD USED FOR DETERMINING SERIAL LEVELS OF TOTAL PSA IS CHANGED, THE LABORATORY MUST PERFORM ADDITIONAL TESTING TO CONFIRM BASELINE VALUES". ADVIA CENTAUR CP AND ATELLICA IM PSA ASSAYS ARE NOT STANDARDIZED TO THE ALTERNATE-METHOD TEST AND THE NUMERICAL RESULTS BETWEEN THE TWO METHODS ARE NOT EXPECTED TO BE IDENTICAL. ALSO, THE IFU INDICATES THAT (B)(4) OF PATIENTS WITH PROSTATE HYPERTROPHY (BPH) HAD PSA RESULTS OF 0.0- 4.0 NG/ML. BASED ON THE AVAILABLE INFORMATION AND A REVIEW WITH MEDICAL AFFAIRS, THE ELEVATED PSA RESULT MAY NOT REPRESENT AN ANALYTICAL MALFUNCTION. A SPECIFIC CAUSE FOR THE DISCORDANT RESULTS WAS UNABLE TO BE DETERMINED. THE ISSUE WAS RESOLVED BY ROUTINE TROUBLESHOOTING; A PRODUCT PROBLEM WAS NOT IDENTIFIED. THE CUSTOMER IS OPERATIONAL AND NO FURTHER ACTIONS ARE REQUIRED. NOTE: IN SECTION H6, CODES FOR INVESTIGATION FINDINGS AND INVESTIGATION CONCLUSIONS WERE UPDATED.

Description of Event or Problem

THE CUSTOMER REPORTS OBSERVATION OF DEPRESSED ADVIA CENTAUR PSA RESULTS WHICH WERE DISCORDANT RELATIVE TO ALTERNATE METHOD TESTING WHILE USING LOT 336. A DEPRESSED RESULT WAS OBSERVED AND NOT REPORTED TO THE PHYSICIAN. THE SAME SAMPLE WAS REPEAT TESTED ON THE ORIGINAL INSTRUMENT AND ANOTHER DEPRESSED RESULT (NO DETAILS PROVIDED) WAS OBSERVED. FOR TROUBLESHOOTING PURPOSES, THE SAME SAMPLE WAS ALSO REPEAT TESTED ON AN ATELLICA IM ANALYZER WHICH PRODUCED SIMILAR DEPRESSED RESULT (NO DETAILS PROVIDED). THE SAMPLE WAS THEN TESTED USING AN ALTERNATE METHOD AND A HIGHER RESULT WAS OBTAINED. THE HIGHER RESULT WAS CONSISTENT WITH THE PATIENT¿S CLINICAL CONDITION AND REPORTED AS CORRECT TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT DEPRESSED PSA RESULT.

Additional Manufacturer Narrative

A CUSTOMER FROM OUTSIDE THE UNITED STATES REPORTED OBSERVATION OF DEPRESSED ADVIA CENTAUR PSA RESULTS WHICH WERE DISCORDANT RELATIVE TO ALTERNATE METHOD TESTING WHILE USING LOT 336. QUALITY CONTROL (QC) RECOVERED WITHIN CUSTOMER ESTABLISHED RANGES. SIEMENS IS EVALUATING THE EVENT.