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U.S. Department of Health and Human Services

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

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GRIFOLS DIAGNOSTIC SOLUTIONS INC. PROCLEIX ULTRIO ELITE ASSAY; HIV-1/HIV-2/HCV/HBV DEVICE Back to Search Results
Catalog Number 731774
Device Problem False Negative Result (1225)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/27/2023
Event Type  Injury  
Event Description
On (b)(6)2023, a representative for kuwait central blood bank in kuwait reported discordant hbv results between different testing methods for a serum sample 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: ue nonreactive; s/co 0.16; (b)(6)2023: dhbv reactive, s/co 4.76; (b)(6)2023: ue dhiv nonreactive (s/co 0.08); (b)(6)2023: ue dhcv nonreactive (s/co 0.00); (b)(6)2023: ultrio elite screening nonreactive (s/co 0.12), confirmation is pending; date unknown: roche cobas mpx hbv reactive, additional details pending.The site noted that this is a known donor who was positive for anti-hbc in 2004 and 2006.The donation was blocked from use.An investigation is ongoing for the discordant hbv result.Remaining sample is being 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 04may2023, a representative for kuwait central blood bank in kuwait reported discordant hbv results between different testing methods for a serum sample 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: ue nonreactive; s/co 0.16.(b)(6) 2023: dhbv reactive, s/co 4.76.(b)(6) 2023: ue dhiv nonreactive (s/co 0.08).(b)(6) 2023: ue dhcv nonreactive (s/co 0.00).(b)(6) 2023: ultrio elite screening nonreactive (s/co 0.12), confirmation is pending date unknown: roche cobas mpx hbv reactive, additional details pending.The site noted that this is a known donor who was positive for anti-hbc in 2004 and 2006.The donation was blocked from use.An investigation is ongoing for the discordant hbv result.Remaining sample is being 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: roche cobas mpx test was performed on (b)(6) 2023.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: -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.
 
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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 Key17035485
MDR Text Key316296030
Report Number2032600-2023-00006
Device Sequence Number1
Product Code QHO
UDI-Device Identifier00859882007672
UDI-Public00859882007672
Combination Product (y/n)N
Reporter Country CodeKU
PMA/PMN Number
BL125652
Number of Events Reported1
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
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date12/15/2023
Device Catalogue Number731774
Device Lot Number704982
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/04/2023
Initial Date FDA Received05/31/2023
Supplement Dates Manufacturer Received05/04/2023
Supplement Dates FDA Received06/30/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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