ATELLICA IM PROSTATE-SPECIFIC ANTIGEN (PSA)

Additional Manufacturer Narrative

MDR 1219913-2025-00217 INITIAL REPORT WAS FILED 8-DEC-2025. CORRECTION: THE PATIENT INFORMATION PROVIDED IN SECTION B7 OF MDR 1219913-2025-00217 INITIAL REPORT WAS INCORRECT. SECTIONS A3 AND B7 OF THIS SUPPLEMENTAL REPORT CONTAIN THE CORRECTED PATIENT INFORMATION. SIEMENS CONTINUES TO INVESTIGATE.

Additional Manufacturer Narrative

SIEMENS COMPLETED THE INVESTIGATION FOR ELEVATED ATELLICA IM PROSTATE-SPECIFIC ANTIGEN (PSA) LOT 344 RESULTS ON SAMPLES FROM A PATIENT (UNDER MANAGEMENT FOR PROSTATE CANCER) THAT WERE DISCORDANT RELATIVE TO RETESTING WITH AN ALTERNATE METHOD AT ANOTHER LAB. SIEMENS RULED OUT REAGENT ISSUES BASED ON A REVIEW OF THE CUSTOMER'S QUALITY CONTROL (QC) WHICH SHOWED RECOVERY WITHIN ACCEPTABLE RANGES AND NO ISSUES WERE REPORTED WITH OTHER PATIENT SAMPLES. SIEMENS REVIEWED INTERNAL DATA AND LOT 344 RECOVERED COMPARABLE TO OTHER LOTS AND MET ALL REAGENT RELEASE CRITERIA. INFORMATION ON THE PATIENT MEDICAL CONDITION AND POSSIBLE MEDICATIONS/SUPPLEMENTS WAS NOT AVAILABLE. SIEMENS ARRANGED HETEROPHILIC BLOCKING TUBES (HBT) TO BE SENT TO THE CUSTOMER SITE. THE HBT RESULTS WERE LOWER (0.05 NG/ML AND 0.06 NG/ML), WHICH INDICATES HETEROPHILIC INTERFERENCE. THE ATELLICA IM PSA ASSAY INSTRUCTIONS FOR USE (IFU) STATES THE FOLLOWING UNDER THE LIMITATIONS SECTION: "PATIENT SAMPLES MAY CONTAIN HETEROPHILIC ANTIBODIES THAT COULD REACT IN IMMUNOASSAYS TO GIVE FALSELY ELEVATED OR DEPRESSED RESULTS. THIS ASSAY IS DESIGNED TO MINIMIZE INTERFERENCE FROM HETEROPHILIC ANTIBODIES." THE IFU STATES THE FOLLOWING UNDER INTERPRETATION OF RESULTS SECTION: "RESULTS OF THIS ASSAY SHOULD ALWAYS BE INTERPRETED IN CONJUNCTION WITH THE PATIENT'S MEDICAL HISTORY, CLINICAL PRESENTATION, AND OTHER FINDINGS." RETURN OF THE PATIENT SAMPLE FOR FURTHER INVESTIGATION IS NOT WARRANTED BECAUSE THE CUSTOMER HAS CONDUCTED APPROPRIATE TESTING. BASED ON THE AVAILABLE INFORMATION, THE CAUSE OF THE DISCORDANCE APPEARS TO BE A PATIENT SPECIFIC ISSUE. THE CUSTOMER HAS NOT HAD REPORTED OTHER SIMILAR ISSUES. THERE IS NO EVIDENCE OF A SYSTEMIC REAGENT OR INSTRUMENT ISSUE. THE CUSTOMER IS OPERATIONAL AFTER REPEATING THE SAMPLE ON AN ALTERNATE METHOD AND HBT TESTING. SIEMENS FILED MDR (B)(4) INITIAL REPORT ON (B)(6) 2025. SIEMENS FILED MDR (B)(4) SUPPLEMENTAL 1 ON (B)(6) 2025. IN SECTION H6 OF THIS REPORT, THE INVESTIGATION FINDING AND CONCLUSION CODES WERE UPDATED BASED ON THE INVESTIGATION RESULTS.

Additional Manufacturer Narrative

THIS INCIDENT OCCURRED OUTSIDE THE UNITED STATES (OUS). THE OUS CUSTOMER OBTAINED AN ELEVATED ATELLICA IM PROSTATE-SPECIFIC ANTIGEN (PSA) LOT 344 ON 2 SAMPLES FROM THE SAME PATIENT, WHO WAS UNDER MANAGEMENT FOR PROSTATE CANCER THAT WERE DISCORDANT RELATIVE TO RETESTING WITH AN ALTERNATE METHOD. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN AND QUESTIONED. THE PATIENT WAS RETESTED ON A DIFFERENT DATE AND RESULT WAS AGAIN ELEVATED. ALIQUOTS OF THE SAMPLES WERE TESTED WITH AN ALTERNATE METHOD, AND RESULTS WERE LOWER AND CONSIDERED CORRECT. THERE ARE NO ALLEGATIONS OF PATIENT HARM, CHANGES IN TREATMENT, OR DELAYS OF DIAGNOSIS IN ASSOCIATION WITH THIS EVENT. THE ASSAY'S INSTRUCTIONS FOR USE (IFU) STATES THE FOLLOWING, UNDER INTERPRETATION OF RESULTS: "RESULTS OF THIS ASSAY SHOULD ALWAYS BE INTERPRETED IN CONJUNCTION WITH THE PATIENT'S MEDICAL HISTORY, CLINICAL PRESENTATION, AND OTHER FINDINGS." SIEMENS IS INVESTIGATING.

Description of Event or Problem

THE CUSTOMER OBTAINED AN ELEVATED ATELLICA IM PROSTATE-SPECIFIC ANTIGEN (PSA) LOT 344 ON 2 SAMPLES FROM THE SAME PATIENT, WHO WAS UNDER MANAGEMENT FOR PROSTATE CANCER THAT WERE DISCORDANT RELATIVE TO RETESTING WITH AN ALTERNATE METHOD. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN AND QUESTIONED. THE PATIENT WAS RETESTED ON A DIFFERENT DATE AND RESULT WAS AGAIN ELEVATED. ALIQUOTS OF THE SAMPLES WERE TESTED WITH AN ALTERNATE METHOD, AND RESULTS WERE LOWER AND CONSIDERED CORRECT. THERE ARE NO ALLEGATIONS OF PATIENT HARM, CHANGES IN TREATMENT, OR DELAYS OF DIAGNOSIS IN ASSOCIATION WITH THIS EVENT.