DIMENSION®

Additional Manufacturer Narrative

AN OUTSIDE OF THE UNITED STATES (OUS) CUSTOMER CONTACTED THE SIEMENS HEALTHCARE DIAGNOSTICS REMOTE SERVICES CENTER (RSC) REGARDING THIRTEEN (13) FALSELY DEPRESSED TACROLIMUS (TAC) PATIENT SAMPLE RESULTS OBTAINED FOR TEN (10) PATIENTS ON A DIMENSION EXL 200 SYSTEM. SIEMENS IS INVESTIGATING THE EVENT.

Description of Event or Problem

THIRTEEN (13) DISCORDANT FALSELY DEPRESSED TACROLIMUS (TAC) PATIENT SAMPLE RESULTS WERE OBTAINED FOR TEN (10) PATIENTS ON A DIMENSION EXL 200 SYSTEM. THE INITIAL TEN (10) DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S) AND THE RESULTS WERE QUESTIONED. THE SAME SAMPLES WERE REPROCESSED ON A NON-SIEMENS SYSTEM AND HIGHER TAC RESULTS, CONSIDERED CORRECT, WERE OBTAINED. CORRECTED REPORTS WERE ISSUED. THE CUSTOMER STATED THAT REPORTING OF PATIENT RESULTS WAS DELAYED APPROXIMATELY 3 HOURS. THERE ARE NO KNOWN REPORTS OF TREATMENT DELAYS OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FALSELY DEPRESSED TACROLIMUS (TAC) RESULTS OR THE DELAY IN REPORTING TAC.

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. SECTIONS H3, H6 AND H8 HAVE BEEN UPDATED TO REFLECT SIEMENS' INVESTIGATION. INITIAL MDR 2517506-2022-00166 WAS FILED 05-JUL-2022.