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

Catalog Number	303715
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/30/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On 02may2024, grifols customer (b)(6) hospital in pakistan reported one sample (id (b)(6)) that was hbsag serology reactive and ultrio elite screening and dhbv nonreactive.Testing summary: (b)(6) 2024 anti-hcv nonreactive (s/co 0.12).(b)(6) 2024 hiv ag/ab nonreactive (s/co 0.19).(b)(6) 2024 hbsag reactive x2 (s/co 1.20, 1.33 s/co).(b)(6) 2024 hbsag confirmatory reactive (s/co 5.04).(b)(6) 2024 hbsag neutralization 98.4307%.(b)(6) 2024 ue screening nonreactive (s/co 0.11) ml 707983.(b)(6) 2024 ue dhbv nonreactive (s.Co 0.01) ml 707983.Date unknown pcr roche cobas hbv: <10 iu/ml.Serology and nat/pcr testing were performed from different tubes.Nat and pcr testing were performed from the same tube.The donation was from a new donor who was cleared based on their universal donor history questionnaire.The donation was not used for transfusion.Grifols requested the results of any anti-hbc serology testing, but that was not performed.The site also performed hbv quantitative testing on the nat testing tube (plasma, k3edta) using a roche cobas pcr test (additional details not provided) and the results were hbv detected at <10 iu/ml.The customer provided the ultrio elite screening and dhbv worklists.The calibrator and ic values look consistent and in the expected range for each target.There is no indication that there was any run performance issue that caused the ue nonreactive result for the sample in question and there were no instrument errors.A review of the device history record (dhr) for ml 707983 was completed.The were no laboratory investigations for hbv sensitivity testing results initiated during qc release testing and there were no retests triggered by initially failing results for sensitivity testing.The following hbv qc panels are tested using the ultrio elite screening and dhbv assays as part of sensitivity testing for qc release of ultrio elite master lots: hbv a at ~11 iu/ml and hbv a at ~4 iu/ml.The hbv panels passed all sensitivity specification criteria.A previous events search was conducted in the grifols customer complaints system searching for related hbv sensitivity issues for ue.There were no results that indicate hbv sensitivity issues with ue ml 707983 or ue in general.The ultrio elite package insert (731771 - 303330 ultrio elite 1k box 2 ivd grfs - 3/2023) shows 95% detection probability of 4.3 iu/ml with 95% fiducial limits of 3.8 - 5.0 iu/ml for the hbv who (97/750) international standard on the ultrio elite screening assay and 4.5 iu/ml with 95% fiducial limits of 4.0 - 5.3 iu/ml on the ultrio elite dhbv assay.Based on the results of hbv quantitative testing results provided by the customer, the hbv concentration of the sample is <10 iu/ml but the actual concentration could not be determined because it is below the limit of quantitation of the assay.It is possible that the hbv concentration of the sample is at or below the ultrio elite screening and dhbv hbv lods and therefore would not be expected to give consistently reactive results but that could not be confirmed.The complaints previous events search and dhr review indicate there is not an issue with hbv sensitivity.This is the final report.

• Brand Name: PROCLEIX ULTRIO ELITE ASSAY
• Common Device Name: 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: 19442925
• Report Number: 2032600-2024-00009
• Device Sequence Number: 12901236
• Product Code: QHO
• UDI-Device Identifier: 00859882007672
• UDI-Public: 00859882007672
• Combination Product (Y/N): N
• Initial Reporter Country: PK
• PMA/510(K) Number: BL125652
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/31/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/15/2025
• Device Catalogue Number: 303715
• Device Lot Number: 707983
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2024
• Initial Report FDA Received Date: 06/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown