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Patient 1
THE FULL NUMBER FOR THE PRODUCT IN QUESTION IS (B)(4) ((B)(4) 2003). IMMUCOR TECHNICAL SUPPORT USED A REMOTE ELECTRONIC CONNECTION METHOD ON (B)(4) 2018 TO ASSESS THE INSTRUMENT TEST WELL IMAGES IN QUESTION WHICH APPEARED AS VISUALLY NEGATIVE. AN IMMUCOR FIELD SERVICE ENGINEER (FSE) VISITED THE CUSTOMER SITE ON 05MAR2018 TO ASSESS THE TESTING INSTRUMENT AND DETERMINED THAT THE ECHO INSTRUMENT IS PERFORMING AS EXPECTED WITH THE EXCEPTION OF THE CAMERA MODULE ABILITY TO APPROPRIATELY IDENTIFY SOME TRUE POSITIVE RESULTS. TWO (2) BLOOD SAMPLES WERE RETURNED FROM THE CUSTOMER SITE TO THE IMMUCOR LABORATORY FOR INVESTIGATION, THAT WERE SEPARATED AS RED BLOOD CELLS AND PLASMA. THE FIRST BLOOD SAMPLE WAS (B)(6), AND WAS DRAWN ON (B)(6) 2018. THE SECOND BLOOD SAMPLE WAS (B)(6), AND WAS DRAWN ON (B)(6) 2018. THE IMMUCOR LABORATORY INVESTIGATION DETERMINED THAT THE PREDOMINANT NATURE OF THE ANTIBODY IN QUESTION WAS IGM. THE PRESENCE OF IGG ANTIBODY COULD NOT BE CONFIRMED. CAPTURE LABELING STATES THAT THE CAPTURE METHOD OF TESTING IS DESIGNED TO DETECT IGG ANTIBODIES ONLY, AND NOT ANTIBODIES OF IGM IN NATURE. COMPLAINTS OF POSITIVE REACTIONS BEING INTERPRETED AS NEGATIVE BY THE GALILEO ECHO CAMERA ALGORITHM ARE BEING CORRECTED UNDER DESIGN CONTROL PROJECT 13-005. THE IMMUCOR TECHNICAL COMMUNICATION (B)(4) IS BEING USED BY THE LAB TO VISUALLY CONFIRM ALL NEGATIVE ASSAY EVENTS REPORTED BY THE ECHO INSTRUMENT. THE INTERNAL IMMUCOR TRACKING NUMBER FOR THIS REPORT IS (B)(4).