ATELLICA IM FREE TRIIODOTHYRONINE (FT3)

Additional Manufacturer Narrative

THIS INCIDENT OCCURRED OUTSIDE THE UNITED STATES (OUS). THE OUS CUSTOMER OBTAINED DISCORDANT LOW ATELLICA IM FREE TRIIODOTHYRONINE (FT3) RESULTS ON MULTIPLE PATIENT SAMPLES THAT WERE DISCORDANT RELATIVE TO RETEST RESULTS. AFTER A NUMBER OF ATELLICA IM FT3 PATIENT SAMPLES WERE TESTED, QUALITY CONTROL (QC) WAS RUN, AND THE RESULTS WERE NOT WITHIN ACCEPTABLE RANGE. THE CUSTOMER INVESTIGATED AND FOUND THAT QC WAS NOT RUN PRIOR TO TESTING PATIENT SAMPLES. THE INITIAL PATIENT SAMPLE RESULTS WERE NOT REPORTED, AND THE SAMPLES WERE REPEATED DUE TO THE QC VIOLATION. THE RETEST RESULTS WERE HIGHER AND REPORTED AS 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 DISCORDANT LOW ATELLICA IM FREE TRIIODOTHYRONINE (FT3) RESULTS ON MULTIPLE PATIENT SAMPLES THAT WERE DISCORDANT RELATIVE TO RETEST RESULTS. AFTER A NUMBER OF ATELLICA IM FT3 PATIENT SAMPLES WERE TESTED, QUALITY CONTROL (QC) WAS RUN, AND THE RESULTS WERE NOT WITHIN ACCEPTABLE RANGE. THE CUSTOMER INVESTIGATED AND FOUND THAT QC WAS NOT RUN PRIOR TO TESTING PATIENT SAMPLES. THE INITIAL PATIENT SAMPLE RESULTS WERE NOT REPORTED, AND THE SAMPLES WERE RETESTED. THE RETEST RESULTS WERE HIGHER AND REPORTED AS CORRECT. THERE ARE NO ALLEGATIONS OF PATIENT HARM, CHANGES IN TREATMENT, OR DELAYS OF DIAGNOSIS IN ASSOCIATION WITH THIS EVENT.

Additional Manufacturer Narrative

SIEMENS FILED INITIAL MDR 1219913-2025-00115 ON 13-JUN-2025. SIEMENS INVESTIGATED AN OUTSIDE OF THE US CUSTOMER REPORT OF DISCORDANT LOW ATELLICA IM FREE TRIIODOTHYRONINE (FT3) RESULTS ON MULTIPLE PATIENT SAMPLES THAT WERE DISCORDANT RELATIVE TO RETEST RESULTS. AFTER A NUMBER OF ATELLICA IM FT3 PATIENT SAMPLES WERE TESTED, QUALITY CONTROL (QC) WAS RUN, AND THE RESULTS WERE NOT WITHIN ACCEPTABLE RANGE. THE CUSTOMER INVESTIGATED AND FOUND THAT QC WAS NOT RUN PRIOR TO TESTING PATIENT SAMPLES. THE INITIAL PATIENT SAMPLE RESULTS WERE NOT REPORTED, AND THE SAMPLES WERE REPEATED DUE TO THE QC VIOLATION. FOR 16 OF SAMPLES, THE RETEST RESULTS WERE HIGHER AND REPORTED AS CORRECT. SIEMENS REVIEWED AVAILABLE INFORMATION AND FOUND THAT THERE WAS MORE THAN ONE REAGENT PACK FOR REAGENT FT3 ON THE ANALYZER AND ONE OF THE PACKS WAS NOT YET USED/PIERCED. ON (B)(6) 2025, DAILY QC WAS PERFORMED ON PIERCED FT3 REAGENT PACK # (B)(6). PACK (B)(6) IS DEPLETED DURING THE DAY, AND THE SYSTEM BEGINS PROCESSING PATIENT SAMPLES WITH PACK #(B)(6) (PREVIOUSLY UNPIERCED). QC IS PERFORMED ONCE EVERY 24 HOURS PER ASSAY, NOT PER INDIVIDUAL REAGENT PACK. THIS BEHAVIOR IS FUNCTIONING AS DESIGNED. SIEMENS PERFORMED FURTHER INVESTIGATION OF THE ATELLICA IM FT3 LOT 296 REAGENT PACK USED IN TESTING THE AFFECTED PATIENT SAMPLES. ALL 16 PATIENT SAMPLES WERE TESTED ON (B)(6) 2025 ON THE SAME FT3 LOT 296 REAGENT PACK (PACK # (B)(6)). THE CUSTOMER DID NOT NOTICE ANY CLUMPED SOLID PHASE OR SOLID PHASE BANDING ON THE SIDE WALLS OR TOPS OF THE FT3 PACK. BASED ON THE AVAILABLE INFORMATION, THE CAUSE OF THE DISCORDANT LOW PATIENT RESULTS ON THIS SINGLE FT3 LOT 296 REAGENT PACK CANNOT BE DETERMINED BUT APPEARS TO BE AN ISOLATED EVENT WHICH WAS RESOLVED BY ROUTINE TROUBLESHOOTING (PLACING A NEW FT3 LOT 296 REAGENT PACK ON THE SYSTEM AND RETESTING PATIENT SAMPLES). THE CUSTOMER IS OPERATIONAL AND RUNNING THE ATELLICA IM FT3 ASSAY WITHOUT FURTHER EVENTS. IN SECTION H6 OF THIS REPORT, THE INVESTIGATION FINDING AND CONCLUSION CODES WERE UPDATED BASED ON THE INVESTIGATION RESULTS.