DIMENSION®

Additional Manufacturer Narrative

AN OUTSIDE OF UNITED STATES (OUS) CUSTOMER CONTACTED THE SIEMENS HEALTHCARE DIAGNOSTICS REMOTE SERVICES CENTER (RSC) REGARDING IMPRECISION FOR SAMPLES PROCESSED IN A LOT-TO-LOT CORRELATION STUDY WITH DIMENSION TACROLIMUS (TAC) LOT GA2286 ON A DIMENSION EXL 200 SYSTEM. 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.

Description of Event or Problem

THE CUSTOMER INFORMED SIEMENS OF IMPRECISE PATIENT SAMPLE RESULTS FOR TACROLIMUS (TAC) WITH LOT GA2286 ON A DIMENSION EXL 200 SYSTEM IN A LOT-TO-LOT CORRELATION STUDY. RESULTS FROM THE CORRELATION STUDY WERE NOT REPORTED TO PHYSICIANS. THERE IS NO INDICATION THAT INITIAL PATIENT SAMPLE TESTING WAS REPROCESSED, AND NO CORRECTED REPORTS WERE ISSUED. THERE IS NO INDICATION THAT ERRONEOUS PATIENT SAMPLE RESULTS WERE REPORTED. THERE IS NO INDICATION THAT PATIENT TREATMENT WAS ALTERED, PRESCRIBED OR DELAYED ON THE BASIS OF IMPRECISE TAC CORRELATION STUDY RESULTS.