DIMENSION®

Additional Manufacturer Narrative

AN OUTSIDE OF THE UNITED STATES (OUS) CUSTOMER CONTACTED THE SIEMENS HEALTHCARE DIAGNOSTICS REMOTE SERVICES CENTER (RSC) REGARDING NINE (9) FALSELY ELEVATED TACROLIMUS (TAC) PATIENT SAMPLE RESULTS OBTAINED ON A DIMENSION EXL 200 SYSTEM. SIEMENS IS INVESTIGATING THE EVENT.

Description of Event or Problem

NINE (9) DISCORDANT FALSELY ELEVATED TACROLIMUS (TAC) PATIENT SAMPLE RESULTS WERE OBTAINED ON A DIMENSION EXL 200 SYSTEM. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S) AND THE RESULTS WERE QUESTIONED. THE SAME SAMPLES WERE REPROCESSED THE FOLLOWING DAY ON THE SAME SYSTEM WITH AN ALTERNATE LOT OF TAC ASSAY AND LOWER RESULTS, CONSIDERED CORRECT, WERE OBTAINED. CORRECTED REPORTS WERE ISSUED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FALSELY ELEVATED TAC PATIENT RESULTS.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION (25-JAN-2023): SIEMENS HEALTHCARE DIAGNOSTICS CONCLUDED THE INVESTIGATION OF THE EVENT. SIEMENS CONFIRMED IMPRECISION FOR QUALITY CONTROL (QC) AND PATIENT SAMPLES WITH DIMENSION TACROLIMUS (TAC) LOTS GA2286, GA3047 AND GA3171. URGENT MEDICAL DEVICE CORRECTION (UMDC) DC-23-03.A.US DATED 30-JAN-2023 WAS SENT TO ALL UNITED STATES (US) CUSTOMERS WHO HAD BEEN SHIPPED THE IMPACTED LOTS. URGENT FIELD SAFETY NOTICE (UFSN) DC-23-03.A.OUS DATED JANUARY 2023 WAS SENT TO OUTSIDE THE US (OUS) CUSTOMERS WHO HAD BEEN SHIPPED THE IMPACTED LOTS. CUSTOMERS WERE ADVISED TO DISCONTINUE USE AND DISCARD THE DIMENSION TACROLIMUS LOTS GA2286, GA3047 AND GA3171. ROOT CAUSE INVESTIGATION IS IN PROGRESS AND CORRECTIVE ACTION UPDATES WILL BE PROVIDED IN MONTHLY STATUS UPDATE REPORTS TO THE FDA AS PER 21 CFR PART 806.10. SECTION H6 HAS BEEN UPDATED TO REFLECT SIEMENS' INVESTIGATION. INITIAL MDR 2517506-2022-00173 WAS FILED 07-JUL-2022.