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

Catalog Number 731774

Device Problem False Negative Result (1225)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/09/2023

Event Type  Injury  

Event Description

On (b)(6) 2023, (b)(6) reported one plasma pool (8 donors) that was nonreactive with ultrio elite ml 704639, but individual donor testing (idt) showed one pool member was reactive in both ue and dhbv, and positive in both hbsag and anti-hbc.The customer initially questioned why the pooled sample was nonreactive and idt was reactive, but now understands the sensitivity difference between a pool and idt.The donation was discarded before use.No sample volume remained for investigation.Relevant tests: pool nat on (b)(6) 2023: pool (mas5934) ue nonreactive (s/co 0.07).Idt serology: on (b)(6) 2023: idt (b)(4) anti-hbc positive.On (b)(6) 2023: idt (b)(4) hbsag positive.Idt nat: on (b)(6) 2023: idt (b)(4) ue reactive (s/co 13.89).On (b)(6) 2023: idt (b)(4) dhiv nonreactive (s/co 0.09, 0.04).On (b)(6) 2023: idt (b)(4) dhcv nonreactive (s/co invalid, 0.00).On (b)(6) 2023: idt (b)(4) dhbv reactive (s/co 24.53, 24.88).No positive results were reported to grifols for the other 7 pool members.Risk analysis: 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 is remote.False negative results do occur but are rare.Overall risk: acceptable.Panther assay specific risk analysis for bloodbank assays, rsk-00854 rev.011 and product safety risk management procedure, 04-03-12-sop version 10.0 were reviewed to assess risk.New risk to patient safety was not identified.There were no related nonconformances 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.The root cause of the initial nonreactive was not determined due to lack of sample.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: the impact to the customer was questioning the ultrio elite results.Though the pooled sample was nonreactive, the sample was consistently reactive when tested individually and the donation was discarded.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.The root cause of the nonreactive ultrio elite result was undetermined due to lack of sample for investigation.Intermittent reactive results are expected in low titer samples (at or below the 95% lod of the ue assay).Dilution of the sample into a pool of 8 donors may have lowered the concentration of hbv in the pool below detectable levels.Review of the qc release data, and a previous events search confirm the ultrio elite assay is working as designed.This is the final report and no additional information is expected.

• Brand Name: PROCLEIX ULTRIO ELITE ASSAY
• Type of Device: 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: 17909401
• MDR Text Key: 325342678
• Report Number: 2032600-2023-00012
• Device Sequence Number: 1
• Product Code: QHO
• UDI-Device Identifier: 00859882007672
• UDI-Public: 00859882007672
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BL125652
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 10/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/15/2023
• Device Catalogue Number: 731774
• Device Lot Number: 704639
• Date Manufacturer Received: 09/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other