Ortho performed retain testing, batch review, complaint review by lot, donor history, and donor complaint review.All results were satisfactory.Sample was not returned to ortho for further investigation.(b)(4).
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Event 2 of 2.Customer reporting isolated problem related to one sample.According to customer, sample with previous history of anti-kell is failing to react during antibody screen on provue analyzer.Approximately a week ago, sample was tested and antibody screen was reported as weak positive by provue with kell positive cells.Patient in question was transfused with packed cells during the past week.Amount of packed cells and date transfused not provided.Customer was not able to tell if patient received any plasma products, but did state patient was on iv fluids.New sample was tested on (b)(6) on provue and now the antibody screen was negative.Testing performed using same lot of mts igg gel cards and vs004.Daily qc testing was acceptable.Issue started on: (b)(6) 17.Frequency: isolated to this one patient.Before calling, the customer reviewed the antibody screen results on the provue for sample in questions and reactions were negative.Ortho care reviewed with customer, the possibility that titer of the antibody is diluted further with fluid and recommend customer repeated antibody screen using manual gel method.Customer agreed to repeat antibody screen ortho care followed up with customer and was told upon repeat testing of sample using manual gel method, the antibody screen was also negative.Customer agreed that issue is related to sample possibly due to dilution of titer of antibody.Testing for manual gel method was performed using the same lot # of gel cards and screening cells.
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