DIMENSION®

Description of Event or Problem

THE CUSTOMER REPORTED TO SIEMENS THAT AN ERRONEOUSLY DEPRESSED CYCLOSPORINE A (CSA) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A DIMENSION RXL MAX HM INTEGRATED CHEMISTRY SYSTEM. THE ERRONEOUSLY DEPRESSED RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLE WAS REPROCESSED TWICE ON THE ORIGINAL DIMENSION RXL MAX HM INTEGRATED CHEMISTRY SYSTEM. HIGHER REPROCESSED RESULTS WERE OBTAINED AND CONSIDERED CORRECT. THE HIGHER REPROCESSED RESULT OF 116.3 NG/ML WAS REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY DEPRESSED CYCLOSPORINE A (CSA) RESULT.

Additional Manufacturer Narrative

AN OUTSIDE OF THE UNITED STATES (OUS) CUSTOMER CONTACTED THE SIEMENS HEALTHCARE DIAGNOSTICS REMOTE SERVICES CENTER (RSC) REGARDING AN ERRONEOUSLY DEPRESSED CYCLOSPORINE A (CSA) RESULT OBTAINED ON A PATIENT SAMPLE ON A DIMENSION RXL MAX HM INTEGRATED CHEMISTRY SYSTEM. SIEMENS HEALTHCARE DIAGNOSTICS CONCLUDED THE INVESTIGATION OF THE EVENT. SIEMENS REVIEWED THE INSTRUMENT DATA FILES AND THE INFORMATION PROVIDED BY THE CUSTOMER. THE REVIEW OF THE QUALITY CONTROL (QC) DATA INDICATED THAT THE INITIAL QC WAS OUT OF RANGE AND THEN RECOVERED WITHIN RANGE AFTER QC ALIQUOT CHANGE ON THE EVENT DATE. THE CUSTOMER CALIBRATED THE CSA ASSAY, WHICH RECOVERED ACCEPTABLY. THE SYSTEM CHECK WAS GOOD AND WITHIN THE ACCEPTABLE LIMITS. THERE WERE NO DIMENSION RXL MAX HM INTEGRATED CHEMISTRY SYSTEM ERRORS OBSERVED, AND THE ISSUE WAS RESOLVED BY REPROCESSING THE SAME SAMPLE ON THE ORIGINAL SYSTEM. THE CAUSE OF THE EVENT IS UNKNOWN. THE CUSTOMER IS OPERATIONAL. THE DEVICE IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION IS REQUIRED.