DIMENSION® CYCLOSPORINE FLEX® REAGENT CARTRIDGE

Additional Manufacturer Narrative

ADDITIONAL INFORMATION (20-AUG-2024): SIEMENS HEALTHCARE DIAGNOSTICS HEADQUARTERS SUPPORT CENTER (HSC) CONCLUDED THE INVESTIGATION OF THE EVENT. HSC REVIEWED THE INFORMATION PROVIDED BY THE CUSTOMER. QUALITY CONTROL (QC) RECOVERED WITHIN THE CUSTOMER'S ACCEPTABLE RANGES. NO REAGENT NOR INSTRUMENT ISSUES WERE IDENTIFIED. THE CAUSE OF THE EVENT IS UNKNOWN. A POTENTIAL PRODUCT ISSUE WAS NOT IDENTIFIED. THE CUSTOMER IS OPERATIONAL. THE DEVICE IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION IS REQUIRED. SECTION H6 HAS BEEN UPDATED TO REFLECT THE HSC INVESTIGATION. INITIAL MDR 2517506-2024-00176 WAS FILED ON 01-JULY-2024.

Description of Event or Problem

THE CUSTOMER REPORTED ONE (1) ERRONEOUSLY ELEVATED CYCLOSPORINE A (CSA) PATIENT SAMPLE RESULT WAS OBTAINED ON A DIMENSION® EXL¿ 200 INTEGRATED CHEMISTRY SYSTEM. THE ERRONEOUSLY ELEVATED PATIENT RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE SAME SAMPLE WAS MANUALLY DILUTED AND REPROCESSED TWO TIMES ON THE SAME DIMENSION® EXL¿ 200 INTEGRATED CHEMISTRY SYSTEM. LOWER RESULTS WERE OBTAINED, CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY ELEVATED CYCLOSPORINE A (CSA) RESULT.

Additional Manufacturer Narrative

AN OUTSIDE UNITED STATES (OUS) CUSTOMER CONTACTED THE SIEMENS HEALTHCARE DIAGNOSTICS REMOTE SERVICES CENTER (RSC) REGARDING ERRONEOUSLY ELEVATED CYCLOSPORINE A (CSA) RESULTS OBTAINED ON ONE (1) PATIENT SAMPLE ON A DIMENSION® EXL¿ 200 INTEGRATED CHEMISTRY SYSTEM. SIEMENS IS INVESTIGATING THE EVENT.