DIMENSION

Additional Manufacturer Narrative

INITIAL MDR 2517506-2021-000130 WAS FILED ON 28-MAY-2021. ADDITIONAL INFORMATION (04-JUNE-2021): SIEMENS HEALTHCARE DIAGNOSTICS HEADQUARTERS SUPPORT CENTER (HSC) CONCLUDED THEIR INVESTIGATION OF THE MICROALBUMIN PROFICIENCY SURVEY FAILURE ON A DIMENSION® EXL¿ 200 SYSTEM. HSC REVIEWED THE INFORMATION PROVIDED BY THE CUSTOMER AND THE INSTRUMENT DATA FILES. HSC EVALUATION SHOWED THAT THE ASSAY RANGE FOR THE MICROALBUMIN (MALB) ASSAY WAS SET INCORRECTLY ON THE SYSTEM AS 1.3-850 MG/L RATHER THAN 1.3-100 MG/L WHICH IS THE ASSAY RANGE LISTED IN THE MALB INSTRUCTIONS FOR USE (IFU). ONCE THIS SETTING WAS CORRECTED, THE SURVEY SAMPLE RESULT RECOVERED ACCEPTABLY. MICROALBUMIN (MALB) QUALITY CONTROL (QC) RECOVERY WAS IN RANGE. THE CUSTOMER WAS PROCESSING THE MALB SURVEY SAMPLES IN A NON-STANDARD MALB CONFIGURATION, OUTSIDE THE ASSAY RANGE INDICATED IN THE INSTRUCTIONS FOR USE FOR THE MALB ASSAY CAUSING THE SURVEY FAILURES. THE CUSTOMER RESET THE MALB ASSAY RANGE TO THE IFU DEFINED ASSAY RANGE AND CONTINUES TO PROCESS ACCEPTABLY WITH NO ISSUES REPORTED. A POTENTIAL PRODUCT ISSUE WAS NOT IDENTIFIED. THE INSTRUMENT IS FULLY OPERATIONAL. 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 THE SIEMENS HEALTHCARE DIAGNOSTICS CUSTOMER CARE CENTER (CCC) AND REPORTED THAT THEY OBTAINED AN UNACCEPTABLE PROFICIENCY SURVEY SAMPLE RESULT FOR MICROALBUMIN ON A PROFICIENCY SURVEY ON THE DIMENSION EXL 200 SYSTEM. SIEMENS IS INVESTIGATING THE EVENT.

Description of Event or Problem

A CUSTOMER REPORTED THAT THEY WERE INFORMED OF A PROFICIENCY SURVEY FAILURE FOR MICROALBUMIN (MALB) ON A DIMENSION® EXL¿ 200 SYSTEM. THE CUSTOMER REPORTED A RESULT THAT WAS LOW OUT OF THE EXPECTED RANGE FOR THE SAMPLE. THE CUSTOMER STATED THAT THEY BELIEVE SOME PATIENT RESULTS COULD HAVE BEEN RELEASED WITH LOWER VALUES. THE CUSTOMER HAS SENT LETTERS TO APPROXIMATELY 21 PATIENTS REQUESTING A NEW SAMPLE BE DRAWN AND TESTED. THE CUSTOMER STATED THAT PATIENTS COULD HAVE RECEIVED DISCORDANT LOW RESULTS. THE CUSTOMER HAS NOT PROVIDED ANY PATIENT TESTING DATA. THE CUSTOMER HAS ALSO NOTIFIED THE PHYSICIANS OF THE POTENTIALLY IMPACTED PATIENTS. THERE HAS BEEN NO ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE POTENTIAL DISCORDANT MALB RESULTS.