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

Catalog Number	9051167
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/31/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6)2022, a representative from (b)(6) china reported discordant testing results between the procleix ultrio plus assay and serology for a plasma sample from a blood donor.The sample was tested twice on ultrio plus master lot (ml) 706154 and the following results were reported: testing date: (b)(6)2023, testing result: nonreactive, s/co 0.23, rlu 21,926.Testing date: (b)(6)2023, testing result: nonreactive, s/co 0.11, rlu 11,288.Serology testing was also completed and the following results were reported: testing date: (b)(6) 2023, testing method: xc hiv ag-ab, testing result: reactive, s/co 3.77 testing date (b)(6)2023, testing method: bio-rad hiv ag-ab, testing result: reactive, s/co 10.00 following initial ultrio plus and serology testing, the sample was sent to the chinese cdc and tested using their western blot hiv-ab test and the following results were reported: testing date: not provided, testing result: reactive.The donation was blocked for use.Grifols requested the ultrio plus run reports for review but the lab declined, citing donor privacy.A previous event search in the grifols complaint system for other ultrio plus hiv sensitivity issues was completed for the previous year.There were no other complaints for hiv sensitivity issues across all lots of procleix ultrio plus during this time.Based on the previous events search, there is no indication of hiv sensitivity issues with ultrio plus ml 706154 or with the ultrio plus assay in general.A review of the device history record (dhr) for ml 706154 and the related split-fill lot was completed.The were no laboratory investigations for sensitivity testing results initiated during qc release testing and there were no retests triggered by initially failing results for sensitivity testing.The following hiv qc panels are tested using the ultrio plus screening and dhiv assays as part of sensitivity testing for qc release of ultrio plus master lots: hiv-1 b 100 c/ml and hiv-1 o 110 c/ml.The hiv panels passed all sensitivity specification criteria.The complaints previous events search and dhr review indicate the assay is working as designed.Grifols customer technical support confirmed that the lab followed up with the donor and determined that the donor was taking hiv antiviral drugs that suppress virus levels.Although the titer of the sample could not be confirmed through investigational hiv quantitative testing, based on the donor information, it is likely that the sample hiv titer is below 95% limit of detection of the ultrio plus assay.Return of the sample for investigational hiv quantitative testing in san diego is not possible as china restricts the export of biological samples.No additional information is expected.This is the final report.

• Brand Name: PROCLEIX ULTRIO PLUS ASSAY
• Common Device Name: HIV-1/HCV/HBV DEVICE
• Manufacturer (Section D): GRIFOLS DIAGNOSTIC SOLUTIONS INC.; 4560 horton street; emeryville CA 94608
• Manufacturer Contact: shi ; 10808 willow ct; san diego, CA 92127 ; 8582020806
• MDR Report Key: 16526898
• Report Number: 2032600-2023-00002
• Device Sequence Number: 14767203
• Product Code: QHO
• UDI-Device Identifier: 00859882007108
• UDI-Public: 00859882007108
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: BL125113/48
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/10/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/15/2024
• Device Catalogue Number: 9051167
• Device Lot Number: 706154
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2023
• Initial Report FDA Received Date: 03/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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