DIMENSION®

Additional Manufacturer Narrative

AN OUTSIDE UNITED STATES (OUS) CUSTOMER CONTACTED A SIEMENS CUSTOMER CARE CENTER (CCC) AND REPORTED THAT FALSELY DEPRESSED TACROLIMUS (TAC) RESULTS WERE OBTAINED ON SIX PATIENT SAMPLES ON A DIMENSION EXL 200 INSTRUMENT. SIEMENS IS EVALUATING THE ISSUE.

Description of Event or Problem

FALSELY DEPRESSED TACROLIMUS (TAC) RESULTS WERE OBTAINED ON SIX PATIENT SAMPLES ON A DIMENSION EXL 200 SYSTEM. THE FALSELY DEPRESSED RESULTS WERE REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULTS. FOUR SAMPLES WERE REPROCESSED ON THE SAME DIMENSION EXL 200 SYSTEM. THE REPROCESSED RESULTS WERE CONSIDERED ERRONEOUS AND NOT REPORTED TO THE PHYSICIAN. ALL SAMPLES WERE REPROCESSED AGAIN ON THE ORIGINAL SYSTEM USING AN ALTERNATE REAGENT LOT. THE REPROCESSED RESULTS OBTAINED USING AN ALTERNATE REAGENT LOT WERE HIGHER THAN THE FALSELY DEPRESSED RESULTS AND REPORTED, AS THE CORRECT RESULTS, TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY DEPRESSED TAC RESULTS.

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 INVESTIGATION FINDINGS CODE AND INVESTIGATION CONCLUSIONS CODE IN SECTION H6 WERE UPDATED TO REFLECT THE ADDITIONAL INFORMATION. SIEMENS FILED INITIAL MDR 2517506-2023-00286 ON 28-DEC-2023. THE DEVICE IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION IS REQUIRED.