ATELLICA IM CYCLOSPORINE (CSA)

Additional Manufacturer Narrative

A CUSTOMER FROM OUTSIDE THE UNITED STATES REPORTED OBSERVATION OF A DEPRESSED ATELLICA IM CYCLOSPORINE (CSA) RESULT RELATIVE TO ALTERNATE-METHOD TESTING. MDR 1219913-2026-00021 WAS INITIALLY SUBMITTED ON 20-JAN-2026. UPDATE, 02-MAR-2026: SIEMENS HAS CONCLUDED THE INVESTIGATION. THE CUSTOMER COMPLAINED OF LOW QUALITY CONTROL (QC) AND PATIENT-RESULT BIAS WHEN USING CSA LOT 055, SINCE NOVEMBER OF 2025. TWO EVENTS WERE IDENTIFIED WHERE PATIENT RESULTS WERE CLINICALLY DISCORDANT RELATIVE TO ALTERNATE-METHOD TESTING PERFORMED AT ANOTHER SITE. [REFER TO MDR 1219913-2026-00021 FOR THE OTHER REPORTED EVENT.] SIEMENS SENT ON-SITE SERVICE, BUT DID NOT FIND ANYTHING SUSPICIOUS AT THE SITE TO EXPLAIN THEIR ISSUES. REVIEW OF QC PERFORMANCE OVER AN EXTENDED PERIOD SHOWED SLIGHT NEGATIVE BIAS, BUT RESULTS WITHIN EXPECTED RANGES WITH GOOD PRECISION. CLOSER EXAMINATION SHOWED THAT QC RESULTS IN NOVEMBER AND JANUARY WERE BELOW TARGET RANGES. ADDITIONAL INFORMATION REQUIRED TO INVESTIGATE THIS ISSUE WAS REQUESTED BUT NOT PROVIDED. THE CUSTOMER HAS INDICATED THAT THEY HAVE SWITCHED TO TESTING CSA USING A DIFFERENT PLATFORM. BASED ON THE AVAILABLE INFORMATION, FURTHER EVALUATION IS NOT POSSIBLE. A SPECIFIC CAUSE FOR THE OBSERVED DISCORDANCE COULD NOT BE DETERMINED, BUT NO SYSTEMIC PRODUCT PROBLEM WAS IDENTIFIED. NOTE: IN SECTION H6, THE CODES FOR INVESTIGATION FINDINGS AND INVESTIGATION CONCLUSIONS HAVE BEEN UPDATED.

Additional Manufacturer Narrative

THIS INCIDENT OCCURRED OUTSIDE THE UNITED STATES (OUS). THE OUS CUSTOMER COMPLAINED OF LOW ATELLICA IM CYCLOSPORINE (CSA) LOT 055 PATIENT RESULTS. A DISCORDANT RESULT WAS IDENTIFIED WHERE A PATIENT SAMPLE TESTED ON (B)(6) 2025 WITH ATELLICA IM CSA RESULTED LOWER THAN A RESULT FROM AN ALTERNATE METHOD OBTAINED AT A DIFFERENT LAB. THERE ARE NO REPORTS OF PATIENT OR USER INTERVENTION OR ADVERSE HEALTH CONSEQUENCES IN ASSOCIATION WITH THIS EVENT. SIEMENS IS INVESTIGATING.

Description of Event or Problem

THE CUSTOMER COMPLAINED OF LOW ATELLICA IM CYCLOSPORINE (CSA) LOT 055 PATIENT RESULTS. A DISCORDANT RESULT WAS IDENTIFIED WHERE A PATIENT SAMPLE TESTED ON (B)(6) 2025 WITH ATELLICA IM CSA RESULTED LOWER THAN A RESULT FROM AN ALTERNATE METHOD OBTAINED AT A DIFFERENT LAB. THERE ARE NO REPORTS OF PATIENT OR USER INTERVENTION OR ADVERSE HEALTH CONSEQUENCES IN ASSOCIATION WITH THIS EVENT.