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

Lot Number	704639
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
On 19oct2022, grifols distributor (b)(4) reported a donation was nonreactive with the procleix ultrio elite assay (ml 704639).It was not tested in the discriminatory assays.The donation was hbv serology positive for hbsag and anti-hbc.It was also hbv pcr reactive in a roche qualitative assay.The donation was also positive for malaria.The donation was not used, and no sample volume remains for investigation.No medical history is available.The testing data is summarized below: (b)(6) 2022 ultrio elite nonreactive.(b)(6) 2022 anti-hbc positive.(b)(6) 2022 anti-hbs negative.(b)(6) 2022 hbsag positive.(b)(6) 2022 hbv pcr reactive (roche).A review of the quality control data for ultrio elite ml 704639 was performed.There were no related quality events found for this lot/batch of product and the product met all release criteria, and no additional complaints have been reported for this type of hbv sensitivity error in the ultrio elite assay for ml 704639 over the last year.The root cause of the false negative result could not be confirmed due to lack of sample for investigation.Intermittent reactive results are expected in low titer samples (below the 95% lod of the ue assay).Review of the qc release data and a previous events search indicate the ultrio elite assay is working as designed.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: amanda doe ; 10808 willow court; san diego, CA 92127 ; 8582020852
• MDR Report Key: 15784167
• Report Number: 2032600-2022-00010
• Device Sequence Number: 14614850
• Product Code: QHO
• UDI-Device Identifier: 00859882007672
• UDI-Public: 00859882007672
• Combination Product (Y/N): N
• Initial Reporter Country: KU
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/11/2022

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: 09/15/2023
• Device Lot Number: 704639
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2022
• Initial Report FDA Received Date: 11/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown