Description of Event or Problem · 1
IN 2008, THE CUSTOMER CONTACTED ORTHO CLINICAL DIAGNOSTICS TO REPORT A FALSE NEGATIVE REACTION FOR ANTI-E WITH VRA118. ON THE PREVIOUS MONTH, A SPECIMEN WAS OBTAINED AND TESTED WITH VRA117. ANTI-C WAS IDENTIFIED, BUT ANTI-E WAS NOT REPORTED. ONE UNIT OF PACKED CELLS WAS TRANSFUSED TO THE METASTATIC MELANOMA PT ON THE FOLLOWING DAY. ON FIVE DAYS PRIOR TO ORIGINAL DATE, A NEW SAMPLE WAS OBTAINED AND TESTED WITH VRA118. ANTI-C WAS IDENTIFIED, BUT ANTI-E WAS NOT REPORTED. TWO UNITS OF PACKED CELLS WERE TRANSFUSED ON THE SAME DAY. CUSTOMER REPORTED THE PT SUFFERED A SEROLOGICAL TRANSFUSION REACTION AS EVIDENCED BY A COFFEE COLORED SAMPLE. ON THE NEXT DAY, A POST TRANSFUSION SAMPLE WAS TESTED WITH VRA118. ANTI-C WAS IDENTIFIED, BUT ANTI-E WAS NOT REPORTED. A PEG/TUBE PANEL WAS ALSO PERFORMED. IN ADDITION TO THE ANTI-C, AN ANTI-E WAS ALSO IDENTIFIED. NO DISCREPANCIES WERE REPORTED WITH QC TESTING.