DIMENSION®

Description of Event or Problem

FOUR (4) DISCORDANT FALSELY DEPRESSED TACROLIMUS (TAC) PATIENT SAMPLE RESULTS WERE OBTAINED ON A DIMENSION EXL 200 SYSTEM. THE FALSELY DEPRESSED PATIENT RESULTS WERE NOT REPORTED TO THE PHYSICIANS. THE SAME SAMPLES WERE REPROCESSED ON THE SAME DIMENSION EXL 200 SYSTEM AND ON AN ALTERNATE DIMENSION EXL 200 SYSTEM. HIGHER RESULTS, CONSIDERED CORRECT, WERE OBTAINED AND REPORTED TO THE PHYSICIANS. THERE WERE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY DEPRESSED TACROLIMUS (TAC) PATIENT RESULTS.

Additional Manufacturer Narrative

AN OUTSIDE OF THE UNITED STATES (OUS) CUSTOMER CONTACTED THE SIEMENS HEALTHCARE DIAGNOSTICS REMOTE SERVICES CENTER (RSC) REGARDING (4) FALSELY DEPRESSED TACROLIMUS (TAC) PATIENT SAMPLE RESULTS OBTAINED ON A DIMENSION EXL 200 SYSTEM. SIEMENS IS INVESTIGATING THE EVENT.

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)(B)(4) DATED (B)(6) 2023 WAS SENT TO ALL UNITED STATES (US) CUSTOMERS WHO HAD BEEN SHIPPED THE IMPACTED LOTS. URGENT FIELD SAFETY NOTICE (UFSN) (B)(4) DATED (B)(6) 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. CORRECTIONS: BASED UPON INVESTIGATION CONCLUSION OF EVENT ATTRIBUTABLE TO ASSAY RATHER THAN INSTRUMENT, CORRECTIONS ARE ENTERED IN SECTIONS D2, D4, G1, G4, H3, H8. SECTION H6 HAS BEEN UPDATED TO REFLECT SIEMENS' INVESTIGATION. INITIAL MDR 2517506-2022-00256 WAS FILED (B)(6) 2022.