DIMENSION®

Additional Manufacturer Narrative

AN OUTSIDE OF THE UNITED STATES (OUS) CUSTOMER CONTACTED THE SIEMENS HEALTHCARE DIAGNOSTICS REMOTE SERVICES CENTER (RSC) REGARDING THE ERRONEOUS TACROLIMUS RESULTS OBTAINED ON PATIENT SAMPLES ON A DIMENSION EXL 200 SYSTEM. SIEMENS IS INVESTIGATING THE EVENT.

Description of Event or Problem

DISCORDANT TACROLIMUS (TAC) RESULTS WERE OBTAINED ON MULTIPLE PATIENT SAMPLES ON A DIMENSION EXL 200 SYSTEM. THE ERRONEOUS RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLES WERE REPROCESSED ON THE ORIGINAL DIMENSION EXL 200 SYSTEM. THE REPROCESSED RESULTS WERE CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO REPORTED EVENT.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION (15-JULY-2024): SIEMENS CONCLUDED THE INVESTIGATION OF THE EVENT. SIEMENS REVIEWED THE AVAILABLE INSTRUMENT DATA FILES AND THE INFORMATION PROVIDED BY THE CUSTOMER. QUALITY CONTROL (QC) RECOVERED OUTSIDE THE CUSTOMER'S ACCEPTABLE RANGES. THE CUSTOMER USED A NEW REAGENT TACROLIMUS (TAC) LOT (LOT# GA4030), PROCESSED A PASSING CALIBRATION, AND PROCESSED QC, WHICH PRODUCED ACCEPTABLE RESULTS. BASED ON THE AVAILABLE INFORMATION FROM THE CUSTOMER AND THE INVESTIGATION, A PRODUCT PROBLEM WAS NOT IDENTIFIED. THE CUSTOMER IS OPERATIONAL. THE DEVICE IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION IS REQUIRED. SECTION H6 HAS BEEN UPDATED TO REFLECT THE SIEMENS INVESTIGATION. INITIAL MDR 2517506-2024-00073 WAS FILED ON 19-FEB-2024.