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 08/28/2023

Event Type  Injury  

Event Description

On (b)(6) 2023, grifols customer donor serv laboratory (b)(6)) reported a discrepant hbv result for organ donor serum sample (b)(6).The sample was nonreactive (s/co 0.12) with ultrio elite (ue) master lot (ml) 706037 when diluted 1:5, and reactive for hbsag in 3/4 reps.The sample was diluted prior to ue testing due to a high level of hemolysis, per instructions in the ue package insert.The customer questioned ultrio elite hbv sensitivity.It is unknown if organ was used for transplant.Relevant tests for sample (b)(6).Nat.(b)(6) 2023: diluted sample ultrio elite nonreactive (s/co 0.06) serology (b)(6) 2023: hbsag eia 30 reactive.(b)(6) 2023: hbsag eia 30 nonreactive.(b)(6) 2023: hbsag eia 30 reactive.(b)(6) 2023: hbsag eia 30 reactive.(b)(6) 2023: od hbc elisa nonreactive.(b)(6) 2023: gs hiv 1+2 plus o eia nonreactive.(b)(6) 2023: od hcv 30 elisa nonreactive.Investigation: sample volume was returned for investigation, received on (b)(6) 2023 2023 for hbv quantitation using aptima hbv quant assay.The procleix ultrio elite instructions for use (ifu) gdss-ifu-000006 v.9.0 specifies "do not freeze whole blood".The aptima hbv quant assay ifu aw-15644, rev.002 specifies "do not freeze specimens in edta, acd, or serum primary collection tubes." the returned samples were not handled according to either ifu.Whole blood in a serum collection tube with no gel separator layer and another transport tube were received thawed after shipment on wet ice.The customer confirmed both samples were frozen before shipment.Because the serum collection tube did not have a gel separator layer, the serum could not be separated from the red blood cells lysed by freezing the whole blood.On (b)(6) 2023, aptima quant hbv tests were attempted on the neat sample, the unknown returned sample, and the neat sample diluted 1:5 in saline.All results were invalid due to instrument clogs caused by the condition of the samples.The root cause of the nonreactive ue result from a diluted serum sample could not be determined due to the quality of the sample returned for investigation.It is possible the sample had low titer hbv and dilution caused the viral concentration to be at or below the (b)(4) limit of detection of the ultrio elite assay, but this could not be confirmed.A review of the quality control data for ultrio elite ml 706037 was performed.There were no related quality events found for this lot/batch of product and the product met all release criteria.The previous events search showed no indication of hbv sensitivity issues with ml 706037.All available information indicates the ultrio elite assay is working as designed.Procleix ultrio elite assay (mn 9051171) (lot number 706037) was manufactured between (b)(6) 2022 and a(b)(6) 2022.The master lot has a kit expiration date of 15jul2024.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.Review of the investigational testing, 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.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.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: 17846329
• MDR Text Key: 324623872
• Report Number: 2032600-2023-00011
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2023
• 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: 706037
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/31/2023
• 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