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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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Hold for em on (b)(6) 2021, (b)(6) in spain reported discordant hbv results for a sample that was originally nonreactive 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 reactive.As a result of the initial nonreactive hbv result, there is a potential transfusion transmitted infection (tti) 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 nonreactive/negative.A donation from (b)(6) 2021 was reactive (s/co 14.12) 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: dhiv nonreactive, dhcv nonreactive, and dhbv reactive (s/co 22.27).Serology testing was also performed and the results were hbsag negative, anti-hbc igm negative, total antihbc negative, antihbe negative, and anti-hbs at 87.52 iu/l.Hbv quantitative testing was also performed and the result was that hbv was present but at a level below the lower limit of detection of the assay used (<10 iu/ml).This donation was blocked and not used.A subsequent donation from 12aug2021 was reactive (s/co 14.79) when tested on the ultrio elite screening assay ml 703028.It was then tested using the ultrio elite discriminatory assays (ml 703038) resulting in the following: dhiv nonreactive, dhcv nonreactive, and dhbv reactive (s/co 24.44).Serology testing was also performed and the results were hbsag negative, anti-hbc igm negative, total antihbc negative, antihbe negative, and anti-hbs at 108.62 iu/l.Hbv quantitative testing was also performed and the result was that hbv was present but at a level below the lower limit of detection of the assay used (<10 iu/ml).This donation was blocked and not used.After these results, the customer tested the archived sample from the (b)(6) 2021 donation, which originally tested nonreactive (s/co 0.06) on the ultrio elite screening assay ml 702238 and negative for hbsag.No other serology testing was performed initially.The testing of the archived sample gave a reactive result (s/co 13.38) on the ultrio elite screening assay ml 703038.There was not enough sample for additional testing.The site also retested the archived sample from the june donation and it gave a nonreactive result (s/co unknown, worklist not provided by customer) on the ultrio elite screening assay ml 703038.The site does not have any additional sample from any of the three donations to send to grifols for investigational testing.On an unknown date, the concentrated red blood cells (rbcs) from the february donation were transfused into a recipient.Grifols has requested additional information and is currently waiting for the results of the post-transfusion hbv 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.Hbv qc panels diluted to approximately 11 iu/ml and 4 iu/ml are used to release ultrio elite master lots.For ml 702238: the hbv 11 iu/ml panel was 100% reactive (specification: >95% reactive) with an average analyte rlu of 1,302,616 (specification: >820,000) during qc release testing.The hbv 4 iu/ml panel was 97% reactive (specification: >6%).For ml 703038: the hbv 11 iu/ml panel was 100% reactive (specification: >95% reactive) with an average analyte rlu of 1,398,668 (specification: >820,000) during qc release testing.The hbv 4 iu/ml panel was 100% reactive (specification: >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 hbv 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 february donation gave nonreactive results on the ultrio elite screening assay (ml 702238) when tested initially and the archive sample gave reactive 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 nonreactive result of the february donation is due to the master lot.The february donation did not have enough sample for quantitative testing to be performed.The actual concentrations of the june and august 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 february, june, and august donations could be due to samples with low hbv titer.Based on the information available and the hbsag negative result, the likely root cause of the discordant results of the february sample between initial and archived sample testing is that the hbv concentration 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 hbv testing results of the february donation concentrated rbc recipient are received.Final report: the customer followed up on the infection status of the recipient of the february donation concentrated rbcs.The patient was tested for hbv and was negative.The details of the testing were not provided to grifols.The customer also notified grifols of a second patient who received a transfusion from the february donation.Throughout (b)(6) 2021 grifols attempted to get information from the customer regarding the post-transfusion status of that recipient.To date, no recipient infection status for the second recipient was received.No additional information is expected.Based on review of the data available, the assay is working as designed.This is the final report.
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