Description of Event or Problem · 1
THIS PROBLEM RELATES TO MEAN CORPUSCULAR VOLUME MCV ASSAY PERFORMANCE ON THE SIEMENS ADVIA 2120I HEMATOLOGY ANALYZERS. IN (B)(6) 2012, RECEIVED A PHYSICIAN COMPLAINT RELATED TO MCV RESULTS BEING REPORTED. THE PHYSICIAN FELT THE MCVS BEING REPORTED BY OUR INSTRUMENTATION WERE FALSELY ELEVATED. AFTER AN INTERNAL INVESTIGATION, WE DETERMINED THAT MEAN PATIENT MCV RESULTS HAD INCREASED 3-4 FL SINCE 2011, EVEN THOUGH QUALITY CONTROL MATERIAL AND PROFICIENCY TESTING RESULTS REMAINED WITHIN ACCEPTABLE LIMITS. DURING THIS PERIOD, MORE PHYSICIANS VOICED THEIR CONCERN OVER A FALSE ELEVATION OF MCV VALUES. SINCE OUR INITIAL DETERMINATION OF THE UNEXPLAINED SHIFT IN MCV VALUES, WE HAVE WORKED WITH SIEMENS DIAGNOSTICS TO DETERMINE THE CAUSE OF THIS INCREASE. ADJUSTMENTS HAVE BEEN MADE FOR THE MCV VALUE BASED ON WHOLE BLOOD CALIBRATIONS TO BRING THE RESULTS BACK INTO EXPECTED RANGES WITHIN OUR OWN LABORATORIES AS NEEDED. HOWEVER, IN ORDER TO ACCOMPLISH A RETURN TO APPROPRIATE POPULATION MEANS, WE HAVE BEEN UNABLE TO USE SIEMENS CALIBRATION PRODUCTS BECAUSE THEY RETURN THE MCV TO THE HIGHER VALUES. THIS PROBLEM IS KNOWN TO NOT BE UNIQUE TO OUR LABORATORIES. WE HAVE BEEN IN CONTACT WITH OTHERS EXPERIENCING THIS DIFFICULTY AND HAVE BEEN INFORMED BY THE MANUFACTURER OF ADDITIONAL LOCATIONS THROUGHOUT THE U.S. WE ARE CONCERNED THAT ALTHOUGH WE ARE BEING SUPPORTED BY SIEMENS IN RESOLVING OUR CONCERNS WITH THIS QUALITY ISSUE, THAT THERE ARE OTHER LABORATORIES WHO ARE UNAWARE OF THIS PROBLEM DUE TO EITHER THEIR VOLUMES OR THEIR PATIENT POPULATIONS. WE HAVE THE ADVANTAGE OF A LARGE, RELATIVELY HEALTHY PATIENT POPULATION TO ALLOW FOR BETTER ANALYSIS OF SHIFTS IN PATIENT MEANS. WE CAN SEE EVIDENCE IN QC PEER EVALUATIONS AND (B)(6) PATHOLOGISTS PROFICIENCY TESTING DATA EVALUATIONS OF HOW OTHER LABORATORIES ARE ADDRESSING, OR NOT ADDRESSING, THIS TECHNICAL PROBLEM. SIEMENS CONTINUES TO INVESTIGATE, BUT NO ANSWERS HAVE BEEN REACHED AND THERE IS NO SIGN OF PROGRESS THAT WILL IMPROVE OF ABILITY TO BE CONFIDENT IN OUR PATIENT'S RESULTS. THEY HAVE BEEN SUPPORTIVE IN THIS INVESTIGATION, BUT ARE STILL UNABLE TO EITHER EXPLAIN OR CORRECT THE ISSUE. THEIR INVESTIGATION IS SLOW AND METHODICAL, WHICH HAS ADVANTAGES FROM A SCIENTIFIC PERSPECTIVE. HOWEVER, THIS APPROACH DOES NOT ALLOW FOR THE FACT THAT END USERS ARE STILL DEPENDENT ON THIS INSTRUMENTATION FOR PATIENT RESULTS. AT THIS POINT WE HAVE BEEN IN DIALOG TOWARD A SOLUTION FOR VERY CLOSE TO A FULL YEAR. DATES OF USE: (B)(6) 2012 - (B)(6) 2013.