ATELLICA IM PROSTATE-SPECIFIC ANTIGEN (PSA)

Additional Manufacturer Narrative

A CUSTOMER FROM OUTSIDE THE UNITED STATES REPORTED OBSERVATION OF ELEVATED ATELLICA IM PROSTATE-SPECIFIC ANTIGEN (PSA) RESULTS WHICH WERE DISCORDANT RELATIVE TO REPEAT TESTING. MDR 1219913-2025-00144 WAS INITIALLY SUBMITTED ON 17-JUL-2025. UPDATE, 14-AUG-2025: SIEMENS HAS CONCLUDED THE INVESTIGATION. THE CUSTOMER HAD IDENTIFIED A QUALITY CONTROL (QC) EXCURSION FOLLOWING A CHANGE OF PSA REAGENT PACK. THE REAGENT PACK HAD BEEN MIXED BEFORE PLACEMENT ON THE SYSTEM, AND NOTHING UNUSUAL WAS NOTED. WHEN 10 SAMPLES WHICH HAD BEEN TESTED WITH THE AFFECTED REAGENT PACK WERE RE-TESTED ON ANOTHER ATELLICA IM SYSTEM WITH IN-RANGE QC, TWO (2) SAMPLES WERE IDENTIFIED AS DISCORDANT (WITH LOWER RESULTS UPON REPEAT). ASSESSMENT OF INSTRUMENT PERFORMANCE INCLUDED A REVIEW OF THE SAMPLE AND REAGENT TRACE FILES FROM THE DATE OF THE DISCORDANT OBSERVATION. THERE IS NO EVIDENCE OF ANY HARDWARE ISSUES AFFECTING DELIVERY OF PSA REAGENTS FOR EITHER THE DISCORDANT PATIENTS OR THE FAILED QC. THE IMMEDIATE ISSUE WAS RESOLVED BY REPEAT-TESTING SAMPLES ON A DIFFERENT SYSTEM WITH A DIFFERENT REAGENT PACK. RETURN OF THE PATIENT SAMPLE FOR FURTHER INVESTIGATION IS NOT WARRANTED BECAUSE DISCORDANT RESULT WAS NOT REPRODUCIBLE. THE SPECIFIC CAUSE FOR THE ELEVATED QC AND PATIENT RESULTS COULD NOT BE DEFINITIVELY IDENTIFIED, BUT THE INCIDENT APPEARS TO BE AN ISOLATED EVENT, AND NO SYSTEMIC PRODUCT PROBLEMS WERE IDENTIFIED. NOTE: IN SECTION H6, THE CODES FOR INVESTIGATION FINDINGS AND INVESTIGATION CONCLUSIONS HAVE BEEN UPDATED.

Description of Event or Problem

THE CUSTOMER REPORTS OBSERVATION OF AN ELEVATED ATELLICA IM PROSTATE-SPECIFIC ANTIGEN (PSA) RESULT WHICH WAS DISCORDANT RELATIVE TO REPEAT TESTING WHEN USING PSA LOT: 341. THE CUSTOMER NOTED A QUALITY CONTROL (QC) EXCURSION FOLLOWING A CHANGE OF PSA REAGENT PACK, WHERE QC LEVEL 1 WAS ABOVE EXPECTED RANGE. 10 SAMPLES WHICH HAD BEEN TESTED WITH THE AFFECTED REAGENT PACK WERE RE-TESTED ON ANOTHER ATELLICA IM SYSTEM WITH IN-RANGE QC. FOR THE PATIENT IN QUESTION, THE LOWER RESULT PRODUCED UPON REPEAT TESTING WAS REPORTED AS CORRECT. THERE ARE NO ALLEGATIONS OF PATIENT HARM, CHANGES IN TREATMENT, OR DELAYS OF DIAGNOSIS IN ASSOCIATION WITH THE OBSERVED DISCORDANCE.

Additional Manufacturer Narrative

A CUSTOMER FROM OUTSIDE THE UNITED STATES REPORTED OBSERVATION OF ELEVATED ATELLICA IM PROSTATE-SPECIFIC ANTIGEN (PSA) RESULTS WHICH WERE DISCORDANT RELATIVE TO REPEAT TESTING. SIEMENS IS INVESTIGATING.