DIMENSION® QUIKLYTE® INTEGRATED MULTISENSOR

Additional Manufacturer Narrative

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

Description of Event or Problem

THE CUSTOMER REPORTED ONE (1) ERRONEOUSLY DEPRESSED SODIUM (NA) PATIENT SAMPLE RESULT WAS OBTAINED ON A DIMENSION® EXL¿ 200 INTEGRATED CHEMISTRY SYSTEM. THE ERRONEOUSLY DEPRESSED SODIUM RESULT WAS REPORTED TO THE PHYSICIAN(S) AND AS A RESULT, IT WAS INDICATED THE PATIENT WAS HOSPITALIZED DUE TO A "CONCERN REGARDING OVER-CORRECTION DUE TO A >6 MMOL/L DELTA CHECK" AND "RISK FOR DEMYELINATION" AND WAS TREATED. THE PATIENT WAS ADMINISTERED 1 LITER OF NORMAL SALINE AND STARTED DDAVP-D5W. THREE (3) SUBSEQUENT SAMPLE DRAWS FROM THE SAME PATIENT WERE PERFORMED AND PROCESSED ON THE ORIGINAL DIMENSION® EXL¿ 200 INTEGRATED CHEMISTRY SYSTEM. HIGHER SODIUM RESULTS WERE OBTAINED FOR ALL THREE SAMPLES, WHICH WERE CONSIDERED CORRECT AND REPORTED. AN ADDITIONAL SAMPLE WAS DRAWN FROM THE SAME PATIENT AND PROCESSED ON AN ALTERNATE DIMENSION® EXL¿ WITH LM INTEGRATED CHEMISTRY SYSTEM. A HIGHER SODIUM RESULT WAS OBTAINED AND CONSIDERED CORRECT. THE ORIGINAL SAMPLE THAT OBTAINED AN ERRONEOUS SODIUM RESULT, WAS RETESTED ON THE ORIGINAL DIMENSION® EXL¿ 200 INTEGRATED CHEMISTRY SYSTEM THE FOLLOWING DAY AND A HIGHER RESULT WAS OBTAINED, CONSIDERED CORRECT, AND REPORTED AS THE AMENDED RESULT. THERE ARE NO KNOWN ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY DEPRESSED SODIUM RESULT.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION (08-OCT-2024): SIEMENS HEALTHCARE DIAGNOSTICS HEADQUARTERS SUPPORT CENTER (HSC) CONCLUDED THE INVESTIGATION OF THE EVENT. HSC EVALUATED THE INFORMATION PROVIDED BY THE CUSTOMER AND THE AVAILABLE INSTRUMENT DATA. QUALITY CONTROL (QC) RECOVERED WITHIN THE CUSTOMER'S ACCEPTABLE RANGES. NO REAGENT OR INSTRUMENT ISSUES WERE IDENTIFIED. THE CAUSE OF THE EVENT IS UNKNOWN. THE DEVICE IS PERFORMING WITHIN SPECIFICATIONS. A POTENTIAL PRODUCT ISSUE WAS NOT IDENTIFIED. NO FURTHER EVALUATION IS REQUIRED. SECTION H6 HAS BEEN UPDATED TO REFLECT THE HSC INVESTIGATION. INITIAL MDR WAS FILED ON 03-OCT-2024.