DIMENSION®

Additional Manufacturer Narrative

AN OUTSIDE OF THE UNITED STATES (OUS) CUSTOMER CONTACTED THE SIEMENS HEALTHCARE DIAGNOSTICS REMOTE SERVICES CENTER (RSC) REGARDING FIFTY-SEVEN (57) FALSELY DEPRESSED TACROLIMUS (TAC) PATIENT SAMPLE RESULTS OBTAINED ON DIMENSION EXL 200 SYSTEMS. MDRS 2517506-2022-00179, 2517506-2022-00180, 2517506-2022-00181, 2517506-2022-00182, 2517506-2022-00183, 2517506-2022-00185, 2517506-2022-00186 AND 2517506-2022-00187 ARE FILED FOR THE SAME EVENT. SIEMENS IS INVESTIGATING THE EVENT.

Description of Event or Problem

FIFTY-SEVEN (57) DISCORDANT FALSELY DEPRESSED TACROLIMUS (TAC) PATIENT SAMPLE RESULTS WERE OBTAINED ON DIMENSION EXL 200 SYSTEMS. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S) AND THE RESULTS WERE QUESTIONED. THE SAME SAMPLES WERE REPROCESSED WITH AN ALTERNATE LOT OF TAC ASSAY ON LATER DATES AND HIGHER TAC RESULTS, CONSIDERED CORRECT, WERE OBTAINED. CORRECTED REPORTS WERE ISSUED. THE CUSTOMER HAS 2 DIMENSION EXL 200 SYSTEMS AND IT IS UNKNOWN ON WHICH INSTRUMENT THE SAMPLES WERE PROCESSED AND/OR REPROCESSED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FALSELY DEPRESSED TACROLIMUS (TAC) 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. SECTIONS H3, H6 AND H8 HAVE BEEN UPDATED TO REFLECT SIEMENS' INVESTIGATION. INITIAL MDR 2517506-2022-00184 WAS FILED 15-JUL-2022. INITIAL MDRS 2517506-2022-00179, 2517506-2022-00180, 2517506-2022-00181, 2517506-2022-00182, 2517506-2022-00183, 2517506-2022-00185, 2517506-2022-00186 AND 2517506-2022-00187 WERE FILED FOR THE SAME EVENT ON 15-JUL-2022. MDR SUPPLEMENTS 2517506-2022-00179 SUPPLEMENT 1, 2517506-2022-00180 SUPPLEMENT 1, 2517506-2022-00181 SUPPLEMENT 1, 2517506-2022-00182 SUPPLEMENT 1, 2517506-2022-00183 SUPPLEMENT 1, 2517506-2022-00185 SUPPLEMENT 1, 2517506-2022-00186 SUPPLEMENT 1 AND 2517506-2022-00187 SUPPLEMENT 1 ARE FILED FOR THE SAME EVENT.