DIMENSION

Additional Manufacturer Narrative

MDR 2517506-2019-00327 WAS FILED ON (B)(4) 2019. ADDITIONAL INFORMATION (B)(4) 2019): SIEMENS HEALTHCARE DIAGNOSTICS HEADQUARTERS SUPPORT CENTER (HSC) CONCLUDED THEIR INVESTIGATION OF THE DISCORDANT, FALSELY DEPRESSED ALBUMIN (ALB) PATIENT RESULTS. THE DIMENSION EXL USES A BROMOCRESOL PURPLE (BCP) ASSAY. PER THE INSTRUCTIONS FOR USE (IFU) FOR THE ALBUMIN METHOD, "BECAUSE OF AN ENHANCED SPECIFICITY OF BCP FOR ALBUMIN, THIS METHOD IS NOT SUBJECT TO GLOBULIN INTERFERENCE." NO PRODUCT OR SYSTEM NON-CONFORMANCE WAS IDENTIFIED BY THIS INVESTIGATION. THE CAUSE OF THIS EVENT IS UNKNOWN. THE DEVICE IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION IS REQUIRED. SECTION H6 HAS BEEN UPDATED TO REFLECT THE HSC INVESTIGATION.

Additional Manufacturer Narrative

THE CUSTOMER CONTACTED SIEMENS CUSTOMER CARE CENTER (CCC) AND REPORTED DISCORDANT, FALSELY DEPRESSED ALBUMIN (ALB) PATIENT RESULTS WERE OBTAINED ON A DIMENSION EXL 200 SYSTEM. SIEMENS IS INVESTIGATING THE EVENT.

Description of Event or Problem

DISCORDANT, FALSELY DEPRESSED ALBUMIN (ALB) RESULTS WERE OBTAINED ON A PATIENT SAMPLE ON A DIMENSION EXL 200 INSTRUMENT. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S) AND WERE QUESTIONED. A NEW SAMPLE WAS PROCESSED USING THE SAME INSTRUMENT AND AN ALTERNATE DIMENSION EXL 200 INSTRUMENT AND LOWER RESULTS WERE OBTAINED. THE NEW SAMPLE WAS ALSO PROCESSED ON AN ALTERNATE NON-SIEMENS INSTRUMENT ON THE SAME DAY AND HIGHER RESULTS WERE OBTAINED. A CORRECTED REPORT WAS ISSUED WITH THE HIGHER RESULTS. THE PATIENT WAS ADMINISTERED AN ALBUMIN INFUSION. THERE WERE NO ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY DEPRESSED ALBUMIN RESULTS OR DUE TO TREATMENT.