ADVIA 120

Description of Event or Problem

IN 2007, THE EMERGENCY ROOM REPORTED A DISCREPANT HEMOGLOBIN (HGB) RESULT OF 8.4 G/DL ON THE ADVIA 120. THE PATIENT RECEIVED A BLOOD TRANSFUSION BASED ON THIS RESULT. SUBSEQUENT TESTING OF THE SAME SAMPLE GAVE A HGB RESULT OF 11.3 G/DL. A FIELD SERVICE ENGINEER WAS SENT TO THE SITE TO INSPECT THE INSTRUMENT. HE CHECKED SAMPLING IN THE AUTOSAMPLER AND FOUND A LOOSE SAMPLE LINE FROM THE AUTOSAMPLER TO THE SELECTOR VALVE. THIS AUTOSAMPLER HYDRAULIC PROBLEM CAUSED A DILUTION OF BOTH THE HGB AND RBC RESULTS, AND THE UNIFORM DILUTION OF BOTH PARAMETERS DID NOT GENERATE A CC ASTERISK (WARNING FLAG). THE ENGINEER ADDRESSED THE HYDRAULIC ISSUE BY REPLACING THE PATHWAY FROM THE AUTOSAMPLER ASPIRATOR TO THE SELECTOR VALVE. HE ALSO ADDRESSED A CLOGGED CENTERING COLLAR AND ADJUSTED THE CONDUCTIVITY VOLTAGE TO SPECIFICATION. THE INSTRUMENT IS NOW PERFORMING AS INTENDED. FOR MEDICAL DEVICE REPORTING PURPOSES THIS EVENT IS CONSIDERED CLOSED.