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

Catalog Number 731770

Device Problem False Negative Result (1225)

Patient Problem Insufficient Information (4580)

Event Date 03/07/2023

Event Type  Injury  

Event Description

On (b)(6) 2023, grifols customer creative testing solutions (cts, florida) reported one organ donor sample (b)(6) that was nonreactive (s/co 0.06 ) with ultrio elite (ue) ml 704640 and reactive (s/co 24.71) in the ultrio elite hbv discriminatory assay (dhbv).It was nonreactive in the discriminatory hiv and discriminatory hcv assays (s/cos 0.05 and 0.00, respectively).The site testing protocol is to test ue and discriminatory assays simultaneously due to time constraints.If ue is nonreactive, their protocol is to cancel discriminatory testing.In this case, they did not follow their protocol.No sample volume is available for investigation.Relevant tests/laboratory data, including dates.(b)(6) 2023: sample (b)(6) ultrio elite nonreactive (s/co 0.06).(b)(6) 2023: sample (b)(6) dhiv invalid.(b)(6) 2023: sample (b)(6) dhcv nonreactive (s/co 0.00).(b)(6) 2023: sample (b)(6) dhbv reactive (s/co 24.71).(b)(6) 2023: sample (b)(6) dhiv nonreactive (s/co 0.05).Investigation.The following additional information was requested, and customer is unwilling/ unable to provide responses: was the organ donor heart beating or non-heart beating? what was the sample type (matrix)? was the sample diluted? was the organ donation released? are other test results available (serology, pcr, other nat)? risk assessment.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.New risk to patient safety was not identified.There were no related nonconformances noted in the manufacturing record or as part of a search of the nonconformance records for this lot number.Product impact: no impact to product was identified.Review of the qc release data and a previous events search in the grifols complaint system indicate that the assay is working as designed.Customer impact: the impact to the customer was questioning the ultrio elite results and their testing protocol.It is unknown if the donation was used.Following iso 14971, grifols risk assessment is based on severity of a harm or impact to human health and the probability of occurrence of harm or impact to human health.Based on the severity rating of critical·and probability rating of remote·, the overall risk posed by a false negative ultrio elite result is determined to be acceptable.Root cause: due to a lack of sample for investigation and lack of information available, the root cause of the nonreactive ue result cannot be determined.A review of the quality control data for ultrio elite ml 704640 was performed.There were no related quality events found for this lot/batch of product and the product met all release criteria.The previous events search showed no indication of hbv sensitivity issues with ml 704640.All available information indicates the ultrio elite assay is working as designed.This is the final report 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 ct; san diego, CA 92127 ; 8582020806
• MDR Report Key: 16690950
• MDR Text Key: 312794407
• Report Number: 2032600-2023-00003
• Device Sequence Number: 1
• Product Code: QHO
• UDI-Device Identifier: 00859882007665
• UDI-Public: 00859882007665
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BL125652
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/15/2023
• Device Catalogue Number: 731770
• Device Lot Number: 704640
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2023
• 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