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

Catalog Number 731774

Device Problem False Negative Result (1225)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/22/2023

Event Type  Injury  

Event Description

On 24may2023, a representative for (b)(6) blood bank in kuwait reported discordant hbv results between different testing methods for a serum sample (k55012320227000) used to screen a plasma donation.The ultrio elite screening assay (ue) and hiv, hcv, and hbv discriminatory assays (dhiv, dhcv, and dhbv, respectively) used ultrio elite master lot (ml) 704982.Testing results are as follows: (b)(6) 2023: anti-hbc positive; (b)(6) 2023: hbsag nonreactive; (b)(6) 2023: roche cobas mpx hbv reactive; (b)(6) 2023: ue nonreactive s/co 0.10; (b)(6) 2023: dhbv reactive s/co 20.63; (b)(6) 2023: ue dhiv nonreactive s/co 0.07; (b)(6) 2023: ue dhcv nonreactive s/co 0.00.The donation was blocked from use based on the roche reactive result.The ultrio elite assay and discriminatory assays were used as confirmation of the roche result.An investigation is ongoing for the discordant hbv result.Remaining sample was requested to be returned to grifols for further evaluation including quantitation.A review of the quality control data for ultrio elite ml 704982 was performed.There were no related quality events found for this lot/batch of product and the product met all release criteria.Follow-up information for this report will be provided when available.

Event Description

On 24may2023, a representative for (b)(6) reported discordant hbv results between different testing methods for a serum sample (b)(4) used to screen a plasma donation.The ultrio elite screening assay (ue) and hiv, hcv, and hbv discriminatory assays (dhiv, dhcv, and dhbv, respectively) used ultrio elite master lot: (ml) 704982.Testing results are as follows: on (b)(6) 2023: anti-hbc positive, on (b)(6) 2023: hbsag nonreactive, on (b)(6) 2023: roche cobas mpx hbv reactive, on (b)(6) 2023: ue nonreactive s/co 0.10, on (b)(6) 2023: dhbv reactive s/co 20.63, on (b)(6) 2023: ue dhiv nonreactive s/co 0.07, on (b)(6) 2023: ue dhcv nonreactive s/co 0.00.The donation was blocked from use based on the roche reactive result.The ultrio elite assay and discriminatory assays were used as confirmation of the roche result.An investigation is ongoing for the discordant hbv result.Remaining sample was requested to be returned to grifols for further evaluation including quantitation.A review of the quality control data for ultrio elite ml 704982 was performed.There were no related quality events found for this lot/batch of product and the product met all release criteria.Follow-up information for this report will be provided when available.Follow-up information: the customer was unable to return the remaining sample for investigation so no hbv quantitation was possible.As a result, the root cause of the nonreactive ultrio elite result could not be determined.Although the nonreactive result could be due to the sample hbv concentration being at or below the ue hbv limit of detection, this could not be confirmed through investigational hbv quantitative testing.Review of the design history data and a previous events search in the grifols complaint system indicate that the assay is working as designed.The customer was able to provide additional sample handling information.The customer shared that due to limited ultrio elite supply on hand, they were using roche as the test of record and the donation was blocked based on the initial reactive roche result.The serum sample in question was tested the day after collection in roche and serology tests.Reactive samples were then frozen and tested in ue and discriminatory assays at a later date for confirmation of the roche result.Thawed samples were not homogenized before ultrio elite and discriminatory testing, and the same tube was used for all testing.Usage of the ultrio elite assay as a confirmatory test rather than a screening test is not part of the intended use of the assay.In addition, not adhering to the sample handling instructions in the package insert (lack of homogenization after thaw) may affect results.This testing methodology may introduce bias against the ultrio elite assay, leading to an excessive number of potential false negative results requiring confirmation by quantitation.The customer reported a total of five occurrences of the same issue (discordant ue and roche hbv results) that grifols reported as mdrs (listed below).In each case, the customer was using the assay outside the package insert instructions for intended use and specimen handling and was unable to return sample for quantitation.1.Initial mdr filed 14apr2023, follow-up filed 25may2023: 2032600-2023-00004-initial and 2032600-2023-00004-final.2.Initial mdr filed 31may2023: 2032600-2023-00006-initial.3.Initial mdr filed 19jun2023: 2032600-2023-00007-initial.4.Initial mdr filed 19jun2023: 2032600-2023-00008-initial.5.Initial (final) mdr filed 23jun2023: 2032600-2023-00009-initial (final).This report is final and no additional information is expected.

• 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: jin shi ; 10808 willow court; san diego, CA 92127 ; 8582020806
• MDR Report Key: 17159667
• MDR Text Key: 317538698
• Report Number: 2032600-2023-00008
• Device Sequence Number: 1
• Product Code: QHO
• UDI-Device Identifier: 00859882007672
• UDI-Public: 00859882007672
• Combination Product (y/n): N
• Reporter Country Code: KU
• PMA/PMN Number: BL125652
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/15/2023
• Device Catalogue Number: 731774
• Device Lot Number: 704982
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/24/2023
• 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