MAUDE Adverse Event Report: GRIFOLS DIAGNOSTIC SOLUTIONS INC. PROCLEIX ULTRIO ELITE ASSAY; HIV/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	07/17/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On 17jul2025, grifols customer creative testing solutions az (use) reported discrepancy between ue screening and discriminatory testing.Testing was performed in (b)(6) 2025 using master lot, procleix ultrio elite, mn 9051171, ln 708157.Master pool sample (b)(6) tested reactive for ultrio elite.All samples in the pool were nonreactive for ue in idt testing.Idt sample (b)(6) tested reactive for dhbv discriminatory test.Alinity serology results for idt sample (b)(6) were anti-hbc (x2) reactive and hbsag nonreactive.The donation was deferred.Samples were not available for investigational testing at grifols.The testing data is summarized below: ultrio elite sample id (b)(6).S/c0 7.92 reactive idt sample (b)(6) s/c0 0.11 nonreactive.Dhbv dt sample (b)(6) s/c0 14.13 reactive.Serology: alinity (done on (b)(6) 2025) anti-hbc 2x reactive hbsag nonreactive hcv nonreactive hiv nonreactive.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 708157.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.No additional information is expected, and this is the final report.

• Brand Name: PROCLEIX ULTRIO ELITE ASSAY
• Common Device Name: HIV/HCV/HBV DEVICE
• Manufacturer (Section D): GRIFOLS DIAGNOSTIC SOLUTIONS INC.; 4560 horton street; emeryville CA 94608
• Manufacturer Contact: sumit khurana ; 10808 willow court; san diego, CA 92127 ; 8585240293
• MDR Report Key: 22822234
• Report Number: 2032600-2025-00003
• Device Sequence Number: 9784270
• Product Code: QHO
• UDI-Device Identifier: 00859882007672
• UDI-Public: 00859882007672
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 08/15/2025

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
• Device Expiration Date: 07/15/2025
• Device Catalogue Number: 303330
• Device Lot Number: 708157
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2025
• Initial Report FDA Received Date: 08/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (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