Description of Event or Problem · 1
ON 08/04/2008, THE CUSTOMER CONTACTED ORTHO CLINICAL DIAGNOSTICS TO REPORT A FALSE NEGATIVE REACTION FOR THE ANTI-E WITH VRA118. IN 2008, 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 AT ABOUT TWO DAYS LATER. AT ABOUT 11 DAYS LATER, 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 IN THE SAME DAY. CUSTOMER REPORTED THE PT SUFFERED A SEROLOGICAL TRANSFUSION REACTION, AS EVIDENCED BY A COFFEE COLORED SAMPLE. IN 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.