DIMENSION QUIKLYTE INTEGRATED MULTISENSOR

Additional Manufacturer Narrative

ADDITIONAL INFORMATION (03-JUNE-2025): SIEMENS HEALTHCARE DIAGNOSTICS SERVICE OPERATIONS SUPPORT (SOS) CONCLUDED THE INVESTIGATION OF THE EVENT. SOS EVALUATED THE INFORMATION PROVIDED BY THE CUSTOMER AND AVAILABLE INSTRUMENT DATA. QUALITY CONTROL (QC) DID RECOVER WITHIN THE CUSTOMER'S ACCEPTABLE RANGES. A CUSTOMER SERVICE ENGINEER (CSE) PERFORMED STANDARD TROUBLESHOOTING ACTIONS, INCLUDING REPLACING ALL IMT TUBINGS ON THE ANALYZER. NO OTHER DISCORDANT RESULTS WERE REPORTED BY THE CUSTOMER AFTER THESE SERVICE ACTIONS. 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. IN SECTION H6, THE INVESTIGATION FINDING AND CONCLUSION CODES WERE UPDATED. INITIAL MDR 2517506-2025-00077 WAS FILED ON 14-MAY-2025.

Additional Manufacturer Narrative

A UNITED STATES CUSTOMER CONTACTED THE SIEMENS HEALTHCARE DIAGNOSTICS REMOTE SERVICES CENTER (RSC) REGARDING AN ERRONEOUSLY DEPRESSED SODIUM (NA) PATIENT SAMPLE RESULT OBTAINED ON A DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM. SIEMENS IS INVESTIGATING THE EVENT.

Description of Event or Problem

THE CUSTOMER REPORTED TO SIEMENS AN ERRONEOUSLY DEPRESSED SODIUM (NA) PATIENT SAMPLE RESULT WAS OBTAINED ON A DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM. THE ERRONEOUSLY DEPRESSED PATIENT RESULT WAS REPORTED TO THE PHYSICIAN AND QUESTIONED. THE SAME SAMPLE WAS REPROCESSED ON THE SAME DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM. A HIGHER RESULT WAS OBTAINED AND NOT REPORTED TO THE PHYSICIAN. THE PATIENT WAS REDRAWN AND REPROCESSED ON THE SAME DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM. A HIGHER RESULT WAS OBTAINED, CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY DEPRESSED SODIUM (NA) RESULT.