ADVIA 120

Description of Event or Problem

UPON OBSERVING A FAILURE OF QUALITY CONTROL RESULTS ON AN ADVIA 120 SYSTEM, THE HEMATOLOGY LAB MANAGER DETERMINED THAT PREVIOUSLY REPORTED HEMOGLOBIN, RBC, AND PLATELET COUNTS WERE ERRONEOUSLY REPORTED AS HIGHER THAN THE ACTUAL SPECIMEN CONCENTRATION. THESE ELEVATED RESULTS WERE NOT DETECTED BY THE HEMATOLOGY LAB PERSONNEL UNTIL APPROXIMATELY 6 HRS LATER WHEN THEY SAW A HIGHER THAN EXPECTED RATE OF DELTA CHECK FAILURES ON THE LIS AND CHECKED THE QUALITY CONTROL RESULTS, WHICH WERE OUT. AS PART OF THE TROUBLESHOOTING EFFORT, THE OPERATOR HOT WASHED THE REAGENT LINES WHICH SEEMED TO CORRECT THE ISSUE. THE SAMPLES WERE REPEATED AND THE HEMOGLOBIN AND RBC RESULTS WERE LOWER THAN THE ORIGINAL VALUES. AS RESULT, ONE PT HAD TO BE CALLED BACK IN FOR A PLATELET TRANSFUSION. A SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE SITE AND FOUND NO EVIDENCE OF SYSTEM MALFUNCTION. UPON REVIEW OF THE CUSTOMER DATA AND A DISCUSSION WITH THE SITE'S LABORATORY STAFF IT WAS DETERMINED THAT THE HGB AND RBC WERE UNDER DILUTING AND GIVING ERRONEOUSLY HIGH RESULTS. BECAUSE BOTH PARAMETERS WERE AFFECTED TO THE SAME DEGREE, THE CAL HBG AND MEASURED HBG AGREED AS DID THE MCHC/CHCM, SO THE RESULTS WERE NOT FLAGGED BY THE INSTRUMENTS. BASED ON THE ACTIONS THE SITE OPERATOR TOOK TO CORRECT THE PROBLEM (HOT WASHED THE REAGENT LINES) THE FSE DETERMINED THAT THE REAGENT PUMP ALL 11 WAY MANIFOLD ASSEMBLY ON THE INSTRUMENT NEEDED REPLACEMENT TO PREVENT THIS ISSUE FROM REOCCURRING.

Additional Manufacturer Narrative

FOR MEDICAL DEVICE REPORTING PURPOSES THIS EVENT IS CONSIDERED CLOSED.