|
On (b)(6) 2020, grifols customer (b)(6) blood center in (b)(6) observed discrepant results in the procleix ultrio elite assay (ue) for individual donor sample id (b)(6).The sample was initially (b)(6) on the ue assay (ml 701549, panther instrument 2090002244).The sample was then tested in two hiv serology tests, wantai hiv ag-ab and bio-rad hiv ag-ab, and both were (b)(6).The sample was retested in ue with the same master lot of reagents on a different panther instrument (2090002246), and the result was (b)(6).The blood center reported the result as a (b)(6) donor and did not use the donation for transfusion.The customer sent the donor sample to the (b)(6) cdc where they performed a confirmatory western blot assay.The result was (b)(6).Review of the device history record (dhr) for procleix ue ml 701549 was performed.Dhr review confirmed that the master lot performed as expected and met all qc release sensitivity criteria.The customer provided a pdf copy of the worklist that included the initial and retest results on ue.No instrument errors were observed and the worklists were valid.On 03jun2020 the customer reported additional information to grifols.Further testing was performed on the donor plasma bag in both the ultrio elite assays (both screening and discriminatory hiv assays) and the roche mpx assay, in multiple replicates.The individual donor sample was (b)(6).The blood center also reported results from testing the donor plasma bag in a pool of six and individually with the roche mpx assay.When tested in a pool, results were (b)(6).When the sample was tested individually, results were (b)(6).Quantitation testing was not performed.In a follow-up interview with the donor, the customer determined (b)(6).(b)(6) impact patient health in a number of ways including (b)(6).Based on the additional testing and customer data provided, the root cause of the inconsistent reactivity in the ultrio elite assay is low titer sample.
|
