DIMENSION®

Additional Manufacturer Narrative

SIEMENS HEALTHCARE DIAGNOSTICS HEADQUARTERS SUPPORT CENTER (HSC) CONCLUDED THEIR INVESTIGATION OF THE DISCORDANT, FALSELY DEPRESSED IMMUNOGLOBULIN M (IGM) RESULT. THE INSTRUCTIONS FOR USE FOR IGM STATES THE FOLLOWING: "MONOCLONAL IMMUNOGLOBULINS MAY SHOW REACTIVITY DIFFERENT FROM THE POLYCLONAL CALIBRATOR, WHICH IN ISOLATED CASES MAY LEAD TO ARTIFICIALLY DECREASED OR NON-LINEAR RESULTS". BASED ON THE PERFORMED ANALYSIS THERE IS NO INDICATION THAT A GENERAL PRODUCT ISSUE EXISTS. THE SAME IGM FLEX WELLS WERE USED TO RUN OTHER PATIENT SAMPLES AS WELL AS QC AND NO FURTHER DISCREPANT RESULTS WERE OBSERVED. THE ISSUE IS LIMITED TO ONE SPECIFIC PATIENT WHO IS KNOWN TO HAVE A MONOCLONAL COMPONENT. THE CAUSE IS UNKNOWN. THE DEVICE IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION IS REQUIRED.

Description of Event or Problem

A DISCORDANT, FALSELY DEPRESSED IMMUNOGLOBULIN M (IGM) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON THE DIMENSION VISTA 1500 SYSTEM. THE RESULT WAS REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLE WAS REPROCESSED THE SAME DAY AND A HIGHER RESULT WAS OBTAINED AND A CORRECTED REPORT WAS ISSUED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT IGM RESULT.