A customer complained after obtaining what was described as a discordant negative grading of a reaction in a crossmatch test for a patient using ortho biovue system in conjunction with their ortho vision max biovue analyzer.Complainant/ complaint reporter: dr.(b)(6) ¿ medical director.Reported on: 12 april 2018 by dr.(b)(6) to ortho care helpdesk.Event date: (b)(6) 2018.Software version: 5.10.0.Reagents: ortho biovue system anti-igg cassette lot igc700a expiry date 27 june 2018 patient information: patient is a (b)(6) male with a diagnosis of gastrointestinal haemorrhage and chronic kidney disease.The patient is blood group b rhd positive with anti-e(rh3), anti-mia and anti-fya (fy1) antibodies.The patient has an auto-antibody in addition to allo-antibodies.On the (b)(6) 2018 the patient had a positive antibody screening with a positive reaction in all 3 cells of the red cell reagent, and a positive (3+ reaction strength) for dat (direct antiglobulin test).The customer said that on (b)(6) 2018, they tested a patient sample and donor for a major crossmatch test in iat (indirect antiglobulin test) using ortho biovue system anti-igg cassette in conjunction with their ortho vision max biovue analyser and that they had obtained a negative/compatible reaction.The customer was expecting a positive/incompatible reaction and said that the reaction in column 5 looked weakly positive on visual inspection.The customer reported that no biased result had been reported to a physician and that the patient concerned had not been harmed as a result of the reported event.
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