GRIFOLS DIAGNOSTIC SOLUTIONS INC. PROCLEIX ULTRIO ELITE ASSAY; HIV-1/HIV-2/HCV/HBV DEVICE,
|
Back to Search Results |
|
Catalog Number 716273 |
Device Problem
False Negative Result (1225)
|
Patient Problem
Insufficient Information (4580)
|
Event Date 02/12/2022 |
Event Type
Injury
|
Event Description
|
On (b)(6) 2022, grifols distributor (b)(6) reported four (b)(6) samples that were (b)(6) in the procleix ultrio elite discriminatory hcv assay (ue dhcv) master lot (ml) 703890.The four samples were also tested in (b)(6) quant, and each had (b)(6) titer greater than equal to (b)(6).No remaining sample volume is available for investigation and there is no option for a new blood draw.No customer information is available at this time.Samples and donors were blocked from use.Though reported to grifols on (b)(6) 2022, the complaint work order was not created until 05apr2022.During qa review of the work order, the complaint was reclassified as potential health and safety complaints" and later the product quality committee determined this event was mdr reportable.Investigation into this delay is ongoing.An investigation is ongoing to determine the root cause for these (b)(6) results in the ultrio elite dhcv assay.The customer is using the discriminatory assays to confirm (b)(6) serology results, rather than initially screening with the ultrio elite multiplex assay and testing samples with (b)(6) results in the discriminatory assays per the package insert.A review of the quality control data for ultrio elite ml 703890 was performed.There were no related quality events found for this lot/batch of product and the product met all release criteria, and no additional complaints have been reported for this type of error in the (b)(6) assay for ml 703890 or any other master lot over the last year.Details for sample handling/ storage and other testing performed have been requested.Preliminary conclusion: specimen handling and storage has not been ruled out as the root cause for the (b)(6) results.The previous events search, and qc release data do not indicate an (b)(6) sensitivity issue with the ue (b)(6) assay.Instructions in the package insert regarding discriminatory testing (initially screening with the ultrio elite multiplex assay and testing samples with (b)(6) results in the discriminatory assays) were not followed by the customer.Since there are 4 different donors, each donor has its own mdr.Follow-up information for this report will be provided when available.
|
|
Event Description
|
On (b)(6) 2022, (b)(6) reported four hcv serology positive samples that were nonreactive in the procleix ultrio elite discriminatory hcv assay (ue dhcv) master lot (ml) 703890.The four samples were also tested in hcv quant, and each had hcv titer greater than equal to 35 iu/ml (above the 2.4 iu/ml lod of the ue dhcv assay).No remaining sample volume is available for investigation and there is no option for a new blood draw.No customer information is available at this time.Samples and donors were blocked from use.Though reported to grifols on (b)(6) 2022, the complaint work order was not created until (b)(6) 2022.During qa review of the work order, the complaint was reclassified as [?]potential health and safety complaints" and later the product quality committee determined this event was mdr reportable.Investigation into this delay is ongoing.An investigation is ongoing to determine the root cause for these nonreactive results in the ultrio elite dhcv assay.The customer is using the discriminatory assays to confirm positive serology results, rather than initially screening with the ultrio elite multiplex assay and testing samples with reactive results in the discriminatory assays per the package insert.A review of the quality control data for ultrio elite ml 703890 was performed.There were no related quality events found for this lot/batch of product and the product met all release criteria, and no additional complaints have been reported for this type of error in the dhcv assay for ml 703890 or any other master lot over the last year.Details for sample handling/ storage and other testing performed have been requested.Preliminary conclusion: specimen handling and storage has not been ruled out as the root cause for the nonreactive dhcv results.The previous events search, and qc release data do not indicate an hcv sensitivity issue with the ue dhcv assay.Instructions in the package insert regarding discriminatory testing (initially screening with the ultrio elite multiplex assay and testing samples with reactive results in the discriminatory assays) were not followed by the customer.Since there are 4 different donors, each donor has its own mdr.See section b6 for further information.Follow-up information for this report will be provided when available.Follow-up information: updated information was received following the initial report indicating the actual awareness date for this event was 31mar2022.Grifols requested additional information regarding sample handling.The customer indicated the separate tubes were used for the serology test and the dhcv test and that samples were stored at minus 40°c prior to dhcv testing.The testing algorithm used by the customer is to test serology positive samples in the appropriate ue discriminatory assay (such as the dhcv test).If found reactive, they discard; if found non-reactive, they repeat serology and also test non-procleix pcr.Conclusion: the root cause of the false negative results could not be confirmed due to lack of sample for investigation.Review of the qc release data and a previous events search indicate the ultrio elite dhcv assay is working as designed.No additional information is expected, and this is the final report.
|
|
Search Alerts/Recalls
|
|
|