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

Catalog Number	303330
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/26/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2024, grifols customer gift of hope (usa), reported a discrepant hbv result for a donor sample tested with procleix ultrio elite assay master lot (ml) 708074.The initial donor sample tested on (b)(6) 2024 yielded a nonreactive result in the screening assay with an s/co of 0.23 and reactive in the discriminatory hbv assay with an s/co of 16.98.The sample was anti-hbc reactive and hbsag nonreactive.The donation was not used and remaining volume of the plasma sample was sent to grifols for investigational testing.Grifols tested the sample in the aptima hbv quant assay on (b)(6) 2025.The results from the two replicates were discordant: "hbv dna not detected" and "20 iu/ml hbv dna".No related quality events were found for this lot/batch of product and the product met all release criteria.A previous events search did not indicate a trend for hbv sensitivity issues with ultrio elite ml 708074.The root cause of the nonreactive ultrio elite result is likely low titer hbv.Intermittent reactivity is expected at concentrations at or below the limit of detection of the assay.The serological profile is consistent with occult hbv infection (obi), which is marked by low to undetectable levels of hbv dna.Grifols will perform additional testing to confirm the assay is working as expected.Additional information will be provided in 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: 21235820
• Report Number: 2032600-2025-00002
• Device Sequence Number: 9178780
• Product Code: QHO
• UDI-Device Identifier: 00859882007672
• UDI-Public: 00859882007672
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/24/2025

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: 03/15/2026
• Device Catalogue Number: 303330
• Device Lot Number: 708074
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/27/2024
• Initial Report FDA Received Date: 01/24/2025
• 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