MAUDE Adverse Event Report: GRIFOLS DIAGNOSTIC SOLUTIONS INC. PROCLEIX ULTRIO ELITE ASSAY; HIV-1/HIV-2/HCV/HBV DEVICE,

Catalog Number 716273

Device Problem False Negative Result (1225)

Patient Problem Hepatitis (1897)

Event Date 02/12/2022

Event Type  Injury  

Event Description

On (b)(6) 2022, grifols distributor (b)(6) hospital ((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.For further information.Follow-up information for this report will be provided when available.

Event Description

On (b)(6) 2022, grifols distributor indus hospital (karachi, pakistan) 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 (b)(6) 2022.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.

• Brand Name: PROCLEIX ULTRIO ELITE ASSAY
• Type of Device: HIV-1/HIV-2/HCV/HBV DEVICE,
• Manufacturer (Section D): GRIFOLS DIAGNOSTIC SOLUTIONS INC.; 4560 horton street; emeryville CA 94608
• Manufacturer Contact: amanda doe ; 10808 willow court; san diego, CA 92127 ; 8582020852
• MDR Report Key: 14163600
• MDR Text Key: 294618923
• Report Number: 2032600-2022-00002
• Device Sequence Number: 1
• Product Code: QHO
• UDI-Device Identifier: 00859882007603
• UDI-Public: 00859882007603
• Combination Product (y/n): N
• Reporter Country Code: PK
• PMA/PMN Number: BL125652
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: 716273
• Device Lot Number: 703890
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other