DIMENSION®

Additional Manufacturer Narrative

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

Description of Event or Problem

TEN (10) DISCORDANT FALSELY DEPRESSED TACROLIMUS (TAC) PATIENT SAMPLE RESULTS WERE OBTAINED ON A DIMENSION EXL 200 SYSTEM. THE FALSELY DEPRESSED RESULTS WERE REPORTED TO THE PHYSICIAN(S), AND THE RESULTS WERE QUESTIONED. THE SAME SAMPLES WERE REPROCESSED USING AN ALTERNATE LOT ON THE SAME DIMENSION EXL 200 SYSTEM. HIGHER RESULTS, CONSIDERED CORRECT, WERE OBTAINED. CORRECTED REPORTS WERE ISSUED. THE CUSTOMER STATED THAT SOME OF THE PATIENTS RECEIVED A TACROLIMUS DRUG INCREASE AND DISCHARGE HAD BEEN POSTPONED. NO FURTHER INFORMATION WAS PROVIDED BY THE CUSTOMER. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES FOR THE PATIENTS DUE TO THE FALSELY DEPRESSED TACROLIMUS (TAC) RESULTS, PROLONGED HOSPITALIZATION, OR TREATMENT.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION (13-MAR-2024): SIEMENS REVIEWED THE INFORMATION PROVIDED BY THE CUSTOMER AND CONCLUDED THE INVESTIGATION OF THE EVENT. SIEMENS INVESTIGATION DID NOT IDENTIFY A MEDICAL DEVICE MALFUNCTION. BASED ON THE INVESTIGATION, SHIPPING AND HANDLING COULD NOT BE RULED OUT AS A CONTRIBUTING FACTOR TO THIS EVENT. THE DEVICE IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION IS REQUIRED. SECTION H6 HAS BEEN UPDATED TO REFLECT THE SIEMENS INVESTIGATION. INITIAL MDR 2517506-2023-00264 WAS FILED ON 30-NOV-2023.