DIMENSION®

Description of Event or Problem

A DISCORDANT FALSELY ELEVATED TACROLIMUS (TAC) PATIENT SAMPLE RESULT WAS OBTAINED ON A DIMENSION XPAND PLUS WITH HM SYSTEM. THE FALSELY ELEVATED RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLE WAS REPROCESSED ON AN ALTERNATE NON-SIEMENS SYSTEM. A LOWER RESULT, CONSIDERED CORRECT, WAS OBTAINED AND REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY ELEVATED TAC RESULT.

Additional Manufacturer Narrative

AN OUTSIDE OF THE UNITED STATES (OUS) CUSTOMER CONTACTED THE SIEMENS HEALTHCARE DIAGNOSTICS REMOTE SERVICES CENTER (RSC) REGARDING A FALSELY ELEVATED TACROLIMUS (TAC) PATIENT SAMPLE RESULT OBTAINED ON A DIMENSION XPAND PLUS WITH HM SYSTEM. SIEMENS IS INVESTIGATING THE EVENT. MDR 2517506-2022-00280 IS FILED FOR THE SAME EVENT.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION (16-DEC-2022): SIEMENS HEALTHCARE DIAGNOSTICS HEADQUARTERS SUPPORT CENTER (HSC) CONCLUDED THE INVESTIGATION OF THE EVENT. HSC REVIEWED THE INFORMATION PROVIDED BY THE CUSTOMER AND THE INSTRUMENT DATA LOGS. A POTENTIAL PRODUCT ISSUE WAS NOT IDENTIFIED BASED ON THE TESTING PERFORMED BY SIEMENS. THE CAUSE OF THE EVENT IS UNKNOWN. THE DEVICE IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION IS REQUIRED. SECTION H6 HAS BEEN UPDATED TO REFLECT SIEMENS' INVESTIGATION. INITIAL MDR WAS FILED ON 18-OCT-2022. INITIAL MDR 2517506-2022-00280 WAS FILED ON 18-OCT-2022 FOR THE SAME EVENT. SUPPLEMENTAL MDR 2517506-2022-00280 SUPPLEMENT 1 IS FILED FOR THE SAME EVENT.