IMMAGE® IMMUNOCHEMISTRY SYSTEM

Description of Event or Problem

THE CUSTOMER REPORTED THAT MULTIPLE IMPRECISE CHEMISTRY PATIENT RESULTS WERE GENERATED FROM AN IMMAGE IMMUNOCHEMISTRY SYSTEM ON (B)(4) 2012. THE EXACT NUMBER OF PATIENTS OR CHEMISTRIES INVOLVED IN THIS EVENT IS UNKNOWN. BECKMAN COULTER INC. ASSESSMENT OF CUSTOMER SUPPLIED DATA INDICATED THE INVOLVEMENT OF ONLY ONE PATIENT'S RESULTS. AN INITIAL ERRONEOUSLY LOW KAPPA LIGHT CHAIN (KAP) RESULT WAS GENERATED FOR THIS PATIENT, WHICH UPON MULTIPLE REPEAT TESTS, GENERATED HIGHER RESULTS WHICH WERE REGARDED AS VALID. AN AMENDED REPORT WAS ISSUED. THE ERRONEOUS KAP RESULT WAS REPORTED OUT OF THE LABORATORY, HOWEVER, THERE WAS NO DEATH, SERIOUS INJURY OR CHANGE TO PATIENT TREATMENT ASSOCIATED OR ATTRIBUTED TO THIS EVENT. MULTIPLE INSTRUMENT CHEMISTRY QUALITY CONTROL (QC) RESULTS WERE OUTSIDE THE CUSTOMER'S ESTABLISHED SPECIFICATION DURING THE TIMEFRAME OF THE EVENT. BECKMAN COULTER INC. ASSESSMENT OF CUSTOMER SUPPLIED INSTRUMENT CHEMISTRY PERFORMANCE DATA INDICATED THAT CALIBRATION RESULTS DURING THE TIMEFRAME OF THIS EVENT WERE ACCEPTABLE. NO PATIENT INFORMATION OR SAMPLE COLLECTION/HANDLING INFORMATION WAS PROVIDED BY THE CUSTOMER

Additional Manufacturer Narrative

SERVICE WAS DISPATCHED TO THE SITE ON (B)(4) 2012 FOR THIS EVENT. ON (B)(4) 2012 THE FIELD SERVICE ENGINEER (FSE) REPLACED THE REAGENT MIXER AND PERFORMED WASH STATION ALIGNMENTS. THE ISSUE REOCCURRED ON (B)(4) 2012, HOWEVER, THE CUSTOMER ONLY NOTED THAT QUALITY CONTROL RESULTS WERE NOT HOLDING PRECISION, NO ADDITIONAL INCORRECT RESULTS WERE GENERATED. SERVICE VISITED ON (B)(4) 2012 AND REBUILT THE VACUUM PUMP. THE FSE REPLACED A BENT REAGENT PROBE AND REPLACED THE HAMILTON VALVE. THE FSE THEM PERFORMED AN OPTICS ALIGNMENTS. UPON COMPLETION OF THE NECESSARY AND VERIFIED REPAIRS, THE INSTRUMENT WAS RETURNED INTO OPERATION. HARDWARE APPEARS TO BE THE ROOT CAUSE OF THIS EVENT.