DIMENSION®

Additional Manufacturer Narrative

ANALYSIS OF THE INSTRUMENT DATA PROVIDED INDICATES THAT THE CAUSE FOR THE DEPRESSED IGM RESULT IS UNKNOWN. THE REPORTED RESULT OF 4535.42 MG/DL WITH AN ASSAY RANGE/DILUTED FLAG WAS REPORTED TO THE PHYSICIAN AND WAS QUESTIONED. THE SIEMENS HEADQUARTERS SUPPORT CENTER REPRESENTATIVE COMPLETED AN INVESTIGATION OF THE INCIDENT AND CONCLUDED THAT THE REPORTED RESULT WAS ACCOMPANIED WITH AN ASSAY RANGE FLAG OR ASSAY RANGE/DILUTED FLAG INDICATING THE RESULT WAS ABOVE THE ASSAY RANGE. PER THE DIMENSION RXL MAX OPERATOR'S GUIDE, THIS RESULT IS NOT REPORTABLE SINCE IT WAS ACCOMPANIED BY THE ASSAY RANGE FLAG. QC WAS WITHIN LABORATORY RANGES ON THE DATE OF TESTING. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

Description of Event or Problem

A DISCREPANT DEPRESSED IMMUNOGLOBULIN M (IGM) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON THE DIMENSION RXL MAX INSTRUMENT RELATIVE TO RESULTS ON AN ALTERNATE METHODOLOGY. THE RESULTS WAS REPORTED TO THE PHYSICIAN WHO QUESTIONED THE RESULT. A HIGHER RESULT WAS OBTAINED ON THE SAME SAMPLE BY THE ALTERNATE METHODOLOGY. THERE IS AN INDICATION THAT PATIENT TREATMENT WAS DELAYED ON THE BASIS OF THE QUESTIONED DEPRESSED IGM RESULTS. A PLATELET REMOVAL TREATMENT WAS PERFORMED ONE DAY LATER ON THE BASIS OF THE HIGHER RESULT OBTAINED ON THE ALTERNATE METHODOLOGY. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE QUESTIONED DEPRESSED IGM RESULT OR THE DELAY IN TREATMENT.