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On (b)(6) 2021, grifols customer hospital (b)(6) reported discordant (b)(6) results for a sample that was originally (b)(6) when tested on (b)(6) 2021 with the procleix ultrio elite assay master lot 702238.
On (b)(6) 2021, an archive sample from the same donor was tested with the procleix ultrio elite assay ml 703038 and was (b)(6).
As a result of the initial (b)(6) result, there is a potential (b)(6) as a result of the infected blood product.
The donor of the samples has been a regular donor since 2014.
Prior to the events described, samples from this donor had always tested (b)(6).
A donation from (b)(6) 2021 was (b)(6) when tested on the ultrio elite screening assay ml 703038.
The donation was then tested using the ultrio elite discriminatory assays from the same ml 703038 resulting in the following: (b)(6).
Grifols has requested additional information and is currently waiting for the results of the post-transfusion (b)(6) testing of the patient.
The estimated date that the results will be available is unknown.
Review of all provided run reports has been completed.
Calibrator results and internal control values were reviewed.
There is no indication of any amplification issues or general problems with the runs performed.
Review of the device history records (dhr) for procleix ultrio elite mls 702238 and 703038 were performed.
Dhr review confirmed that the master lots performed as expected and met all qc release specificity and sensitivity criteria.
(b)(6) qc panels diluted to approximately 11 iu/ml and 4 iu/ml are used to release ultrio elite master lots.
(b)(6).
A review of grifols complaint records created for ultrio elite hbv sensitivity issues from 3 years prior to the occurrence date through the present was completed.
There is no complaint information that indicates an (b)(6) sensitivity problem with ultrio elite mls 702238 and 703038 or the ultrio elite assay in general.
The procleix ultrio elite package insert (503049en rev.
005) shows hbv who (97/750) international standard 95% detection probability of 4.
3 iu/ml with 95% fiducial limits of 3.
8-5.
0 iu/ml for the ultrio elite screening assay.
A sample below the limit of detection of the assay would be expected to give nonreactive or intermittently reactive results.
The (b)(6) donation gave (b)(6) results on the ultrio elite screening assay (ml 702238) when tested initially and the archive sample gave (b)(6) results on the ultrio elite assay (ml 703038).
There is no indication based on the qc release data for mls 702238 and 703038 or the previous events search that the initial (b)(6) result of the (b)(6) donation is due to the master lot.
The (b)(6) donation did not have enough sample for quantitative testing to be performed.
The actual concentrations of the (b)(6) and (b)(6) donations could not be determined because they were below the limit of detection of the quantitative assay used, but the overall results of all testing for the (b)(6) donations could be due to samples with low (b)(6).
Based on the information available and the (b)(6) result, the likely root cause of the discordant results of the (b)(6) sample between initial and archived sample testing is that the (b)(6) in the donation is below the limit of detection of the ultrio elite assay an update to this report will be filed when the post-transfusion (b)(6) testing results of the (b)(6) donation concentrated rbc recipient are received.
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