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 01/21/2024

Event Type  Injury  

Event Description

Customer (b)(6) university (saudi arabia) reported on 05feb2024 initial ultrio elite nonreactive results for donor sample using ln 706570.Serology results were reactive for hbsag and anti-hbc.Discriminatory dhbv tests were reactive.Repeat ue test using same tube was reactive.Donor admitted to having hbv.Donation was not used for transfusion.No remaining sample was available for investigation.Summary of testing: (b)(6) 2024.Sample (b)(6).Results: ultrio elite nonreactive s/co 0.12.Sample (b)(6).(serology tube from the same donor) results: hbsag reactive (3 replicates).Anti-hbc reactive (3 replicates).(b)(6) 2024.Sample (b)(6).(serology tube from the same donor) results: ultrio elite reactive s/co 12.34.Dhbv reactive s/co 23.49.In addition, the customer indicated that pcr testing took place in (b)(6) 2023.In this particular case, nat and serology were carried out on (b)(6) 2024.Since the conventional practice involves conducting pcr as a confirmatory test following nat and serology, it is highly probable that the pcr tested a sample obtained from a prior draw.Consequently, the pcr outcome from december 2023 will not be considered in assessing the performance of the ultrio elite assay.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.Gdss-rsk-000044, panther assay specific risk analysis for bloodbank assays (rsk-00854) and product safety risk management procedure, 04-03-12-sop 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.Donation was not used for transfusion.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.Investigational testing is in progress.Follow-up information for this report will be provided when available.

Event Description

Customer king abdulaziz university (saudi arabia) reported on 05feb2024 initial ultrio elite nonreactive results for donor sample using ln 706570.Serology results were reactive for hbsag and anti-hbc.Discriminatory dhbv tests were reactive.Repeat ue test using same tube was reactive.Donor admitted to having hbv.Donation was not used for transfusion.No remaining sample was available for investigation.Summary of testing: (b)(6) 2024.Sample (b)(6) results: ultrio elite nonreactive s/co 0.12.Sample (b)(6) (serology tube from the same donor) results: hbsag reactive (3 replicates) anti-hbc reactive (3 replicates).22jan2024.Sample 1109634 (serology tube from the same donor) results: ultrio elite reactive s/co 12.34.Dhbv reactive s/co 23.49.In addition, the customer indicated that pcr testing took place in (b)(6) 2023.In this particular case, nat and serology were carried out on (b)(6) 2024.Since the conventional practice involves conducting pcr as a confirmatory test following nat and serology, it is highly probable that the pcr tested a sample obtained from a prior draw.Consequently, the pcr outcome from (b)(6) 2023 will not be considered in assessing the performance of the ultrio elite assay.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.Gdss-rsk-000044, panther assay specific risk analysis for bloodbank assays (rsk-00854) and product safety risk management procedure, 04-03-12-sop 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.Donation was not used for transfusion.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.Investigational testing is in progress.Follow-up information for this report will be provided when available.23may2024: no further info is available.This is the final report.

• 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: 18822857
• MDR Text Key: 336736424
• Report Number: 2032600-2024-00001
• Device Sequence Number: 1
• Product Code: QHO
• UDI-Device Identifier: 00859882007672
• UDI-Public: 00859882007672
• Combination Product (y/n): N
• Reporter Country Code: SA
• PMA/PMN Number: BL125652
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/23/2024

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 Operator: Health Professional
• Device Catalogue Number: 731774
• Device Lot Number: 706570
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/05/2024
• Initial Date FDA Received: 03/01/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/23/2024
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other