DIMENSION®

Description of Event or Problem

FOUR (4) DISCORDANT FALSELY DEPRESSED TACROLIMUS (TAC) PATIENT SAMPLE RESULTS WERE OBTAINED ON A DIMENSION EXL W/LM SYSTEM. THE FALSELY DEPRESSED RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLES WERE REPROCESSED ON AN ALTERNATE DIMENSION SYSTEM AT ANOTHER FACILITY. HIGHER RESULTS, CONSIDERED CORRECT, WERE OBTAINED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY DEPRESSED TAC RESULTS.

Additional Manufacturer Narrative

AN OUTSIDE OF THE UNITED STATES (OUS) CUSTOMER CONTACTED THE SIEMENS HEALTHCARE DIAGNOSTICS REMOTE SERVICES CENTER (RSC) REGARDING FOUR (4) FALSELY DEPRESSED TACROLIMUS (TAC) RESULTS OBTAINED ON PATIENT SAMPLES ON A DIMENSION EXL WITH LM 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, H4, H8. SECTION H6 HAS BEEN UPDATED TO REFLECT SIEMENS' INVESTIGATION. INITIAL MDR 2517506-2022-00258 WAS FILED (B)(6) 2022.