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	11/28/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2024, grifols distributor (b)(4) (on behalf of customer (b)(6), reported a discrepant hiv result for a donor sample tested with procleix ultrio elite assay master lot: (ml) 708054.The initial donor sample tested on (b)(6) 2024 yielded a nonreactive result with an s/co of 0.08.The sample was hiv serology positive in the diasorin assay.The diasorin results were deleted for unknown reasons.The sample was sent to an offsite clia laboratory for additional testing.On (b)(6) 2024, the sample was found nonreactive in the abbott architect anti-hiv assay.The customer accepted the agreement between procleix and abbott results (nonreactive for hiv) as the valid sample interpretation and no sample remained for investigation.No related quality events found for this lot/batch of product and the product met all release criteria.A previous events search did not indicate a trend for hiv sensitivity issues with ultrio elite ml 708054.The root cause of the disagreement between the ultrio elite and abbott results as compared to the diasorin results could not be determined.False positive results in the diasorin assay due to contamination or assay performance could not be ruled out.Another possible root cause of the nonreactive ultrio elite result is low titer hiv.Intermittent reactive results are expected in low titer samples (at or below the 95% lod of the assay).The ultrio elite assay was determined to be working as designed.Risk assessment: severity: critical.A single blood screening false negative (fn) result can cause multiple infections.The severity of a blood screening false negative is critical.Probability: remote.The probability of a false negative result in ml 708054 is remote based on the previous events search.False negative results do occur but are rare.Overall risk: acceptable.Panther assay specific risk analysis for bloodbank assays, gdss-rd-rsk-000043 rev.2.0 and product safety risk management procedure, gdss-ms-sop-000004 version 13.0 were reviewed to assess risk.New risk to patient safety was not identified.There were no related nonconformance's noted in the manufacturing record or as part of a search of the nonconformance records for this lot number.Product impact: no impact to product was identified.Review of the qc release data and a previous events search in the grifols complaint system indicate that the assay is working as designed.Customer impact: no record showed the donation was used.The impact to the customer was questioning the discordant ue result.Following iso 14971, grifols risk assessment is based on severity of a harm or impact to human health and the probability of occurrence of harm or impact to human health.Based on the severity rating of ·critical· and probability rating of ·remote·, the overall risk posed by a false negative ultrio elite result is determined to be acceptable.No further information is expected, 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: 21164075
• Report Number: 2032600-2025-00001
• Device Sequence Number: 4538830
• Product Code: QHO
• UDI-Device Identifier: 00859882007672
• UDI-Public: 00859882007672
• Combination Product (Y/N): N
• Initial Reporter Country: ID
• 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): 01/15/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/15/2026
• Device Catalogue Number: 303330
• Device Lot Number: 708054
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2024
• Initial Report FDA Received Date: 01/15/2025
• 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