| Catalog Number 731774 |
| Device Problem
False Negative Result (1225)
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| Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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| Event Date 03/02/2023 |
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Event Type
Injury
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Event Description
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On (b)(6) 2023 grifols customer, centro regional de transfusión sanguínea de granada in spain, reported a nonreactive result for a pool of 4 (p4) that contained a donor sample (b)(6) that was confirmed hcv positive based on additional testing.The following is a summary of the testing completed for the donor in the following format: testing date, sample, testing method, and result.Testing was completed in the individual donor sample unless otherwise noted.(b)(6) 2023, nat primary tube in p4, ultrio elite screening, nonreactive (s/co 0.12) (b)(6) 2023, serology primary tube (e00212349889521), anti-hcv, positive (b)(6) 2023, plasma bag, anti-hcv**, positive (b)(6)2023, nat primary tube (e00212349889521), ib* hcv, positive (b)(6) 2023, serology primary tube (e00212349889521), ib* hcv, positive (b)(6) 2023, archive from nat primary tube (e00212349889521), ib* hcv, positive (b)(6) 2023, serology secondary tube (frozen) (e00212349889521), ultrio elite screening, reactive (s/co 8.48) (b)(6) 2023, serology secondary tube (frozen) (e00212349889521), ultrio elite dhcv, reactive (s/co 23.71) (b)(6) 2023, serology secondary tube (frozen) in p4 with e00212349889521 and 3 known negative samples, ultrio elite screening, reactive (s/co 7.39) (b)(6) 2023, (b)(6) 2023, serology secondary tube (frozen) (e00212349889521), roche hcv quantitative assay, hcv present (527iu/ml) **detail on this testing (pool or individual sample) is pending *full name of "ib" is pending and will be clarified in the follow-up report.The customer used ultrio elite ml 705439 for all ue testing.Grifols has requested additional information regarding the delay in between the p4 and serology testing compared to when the idt ue testing was performed.There is no additional sample left for investigational testing at grifols.An investigation into the nonreactive p4 testing result on 02mar2023 is ongoing.The ultrio elite screening run report for the nonreactive p4 was reviewed.The calibrator and internal control values look consistent and in the expected range for each target.There is no indication that there was a run performance issue that caused the nonreactive result for the pool in question.The grifols fse reviewed the logs for the panther instrument used for testing.There were no signs of sample dispense issues for the nonreactive p4.He also reviewed the logs for the xpress instrument used to pipet the p4.Review of the data for the sample showed correct aspiration and dispense values.A review of the device history record (dhr) for ultrio elite ml 705439 was completed.The were no laboratory investigations for hcv sensitivity testing results initiated during qc release testing and there were no retests triggered by initially failing results for sensitivity testing.Testing passed all hcv sensitivity specification criteria.The customer testing (serology, additional nat testing, hcv quantitation) confirmed that the donation is hcv positive but the nat primary draw tube and the initial p4's quantitation were not confirmed (no quant testing performed on those samples) so the actual hcv concentration of the p4 that was tested on ue is unknown.Without knowing the hcv concentration of the p4, it is unknown if the nonreactive result was due to an issue in the pooling process that resulted in the pool being at or below the lod of the ue assay.Grifols has requested additional information to help determine if a problem with the pool contributed to the nonreactive result the donation was not used for transfusion.All components from the blood donation were rejected based on the serology results and the donor was rejected follow-up information for this report will be provided when available.
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Event Description
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On (b)(6) 2023 grifols customer, (b)(6), reported a nonreactive result for a pool of 4 (p4) that contained a donor sample (b)(4) that was confirmed hcv positive based on additional testing.The following is a summary of the testing completed for the donor in the following format: testing date, sample, testing method, and result.Testing was completed in the individual donor sample unless otherwise noted.On (b)(6) 2023, nat primary tube in p4, ultrio elite screening, nonreactive (s/co 0.12).On (b)(6) 2023, serology primary tube (b)(4), anti-hcv, positive.On (b)(6) 2023, plasma bag, anti-hcv**, positive.On (b)(6) 2023, nat primary tube (b)(4), ib / hcv, positive.On (b)(6) 2023, serology primary tube (b)(4), ib / hcv, positive.On (b)(6) 2023, archive from nat primary tube (b)(4), ib / hcv, positive.On (b)(6) 2023, serology secondary tube (frozen) (b)(4), ultrio elite screening, reactive (s/co 8.48).On (b)(6) 2023, serology secondary tube (frozen) (b)(4), ultrio elite dhcv, reactive (s/co 23.71).On (b)(6) 2023, serology secondary tube (frozen) in p4 with (b)(4) and 3 known negative samples, ultrio elite screening, reactive (s/co 7.39).On (b)(6) 2023, serology secondary tube (frozen) (b)(4), roche hcv quantitative assay, hcv present (527iu/ml).Detail on this testing (pool or individual sample) is pending full name of "ib" is pending and will be clarified in the follow-up report.The customer used ultrio elite ml 705439 for all ue testing.Grifols has requested additional information regarding the delay in between the p4 and serology testing compared to when the idt ue testing was performed.There is no additional sample left for investigational testing at grifols.An investigation into the nonreactive p4 testing result on (b)(6) 2023 is ongoing.The ultrio elite screening run report for the nonreactive p4 was reviewed.The calibrator and internal control values look consistent and in the expected range for each target.There is no indication that there was a run performance issue that caused the nonreactive result for the pool in question.The grifols fse reviewed the logs for the panther instrument used for testing.There were no signs of sample dispense issues for the nonreactive p4.He also reviewed the logs for the xpress instrument used to pipet the p4.Review of the data for the sample showed correct aspiration and dispense values.A review of the device history record (dhr) for ultrio elite ml 705439 was completed.The were no laboratory investigations for hcv sensitivity testing results initiated during qc release testing and there were no retests triggered by initially failing results for sensitivity testing.Testing passed all hcv sensitivity specification criteria.The customer testing (serology, additional nat testing, hcv quantitation) confirmed that the donation is hcv positive but the nat primary draw tube and the initial p4's quantitation were not confirmed (no quant testing performed on those samples) so the actual hcv concentration of the p4 that was tested on ue is unknown.Without knowing the hcv concentration of the p4, it is unknown if the nonreactive result was due to an issue in the pooling process that resulted in the pool being at or below the lod of the ue assay.Grifols has requested additional information to help determine if a problem with the pool contributed to the nonreactive result.The donation was not used for transfusion.All components from the blood donation were rejected based on the serology results and the donor was rejected.Follow-up information for this report will be provided when available.Updated report.The customer was not able to provide any additional information.Root cause could not be confirmed due to lack of sample (p4 and nat primary tube were not available for quantitative testing).The customer testing (serology, additional nat testing, hcv quantitation) confirmed that the donation is hcv positive but the nat primary draw tube and the initial p4 quantitation were not confirmed (no quant testing performed on those samples) so the actual hcv concentration of the p4 that was tested is unknown.Without knowing the hcv concentration of the p4, it is unknown if the nonreactive result was due to an issue that resulted in the pool being at or below the lod of the ue assay or if the assay did not detect a sample above the lod for that target.Review of the qc release data indicates that the assay is working as designed.Risk assessment found the following: panther assay specific risk analysis for bloodbank assays, rsk-00854 rev.011 and product safety risk management procedure, 04-03-12-sop version 9.0 were reviewed to assess risk.This complaint is assessed as a false negative result which has a severity of rating of critical.Based on the previous event search results, probability of a false negative result is remote.The overall risk based on severity and probability is acceptable.New risk to patient safety was not identified.There were no related nonconformances noted in the manufacturing records or as part of a search of the nonconformance records that could impact hcv sensitivity for ultrio elite ml 705439.Product impact: impact to product is unknown as root cause could not be established.Review of the device history record (dhr) for procleix ultrio elite ml 705439 was performed.Dhr review confirmed that the master lot performed as expected and met all qc release specificity and sensitivity criteria.A review of grifols complaint records created for ultrio elite hcv sensitivity and specificity issues from 12 months prior to the occurrence date through the present was completed.There is no complaint information that indicates an hcv sensitivity problem with ultrio elite ml 705439 or the ultrio elite assay in general.Customer impact: the impact to the customer was questioning of the assay results due to a discordant p4 testing results result when compared to serology and other nat testing results.The donation was blocked for use.Regarding "detail on this testing (pool or individual sample) is pending", the testing (on (b)(6) 2023, plasma bag, anti-hcv, positive.) was completed using individual donor sample.Regarding "full name of "ib", the full name is immunoblot.
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Search Alerts/Recalls
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