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

Catalog Number 731770

Device Problem False Negative Result (1225)

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

Event Date 02/17/2024

Event Type  Injury  

Event Description

On (b)(6) 2024, (b)(6) (usa) reported that they had one tissue/organ donor sample (id: (b)(6) with discordant hbv results.All ultrio elite (ue) testing was completed using ml 706881.A summary of the testing results are as follows: on (b)(6) 2024 anti-hbc: reactive in triplicate (s/co 8.66, 9.07, 8.18).On (b)(6) 2024 hbsag: nonreactive (s/co 0.25).On (b)(6) 2024 hiv combo: nonreactive (s/co 0.08).On (b)(6) 2024 anti-hcv: nonreactive (s/co 0.03).On (b)(6) 2024 ue screening: nonreactive (s/co 0.23).On (b)(6) 2024 ue dhbv reactive (s/co 4.59 ).On (b)(6) 2024 ue dhiv nonreactive (s/co 0.10).On (b)(6) 2024 ue dhcv nonreactive (s/co 0.00).No organs or tissue were transplanted from the donor.No known history of hbv was noted in donor medical history.No donor sample is available for investigational testing.The customer provided the ultrio elite screening worklist.The calibrator and ic values look consistent and in the expected range for each target.There is no indication that there was any run performance issue that caused the ue screening non-reactive result for the sample in question and there were no instrument errors.Serology results were reviewed and evaluated against the cdc interpretation of hbv serology result guidance.Based on the results available, the serology testing indicates that the donor either has a resolved infection or an occult infection.A resolved or occult infection would likely result in a low titer sample that is at or below the limit of detection of the ultrio elite assay.The actual concentration of the sample cannot be determined because it is not available for investigational testing.A review of the device history record (dhr) for ml 706881 was completed.The were no laboratory investigations for hbv sensitivity testing results initiated during qc release testing and there were no retests triggered by initially failing results for sensitivity testing.The following hbv qc panels are tested using the ultrio elite screening and dhbv assays as part of sensitivity testing for qc release of ultrio elite master lots: hbv a at ~11 iu/ml and hbv a at ~4 iu/ml.The hbv panels passed all sensitivity specification criteria.A previous events search was conducted in the grifols customer complaints system searching for related hbv sensitivity issues for ue.There were no results that indicate hbv sensitivity issues with ue ml 706881 or ue in general.The complaints previous events search and dhr review indicate the assay is working as designed.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: 19085310
• MDR Text Key: 339878487
• Report Number: 2032600-2024-00003
• Device Sequence Number: 1
• Product Code: QHO
• UDI-Device Identifier: 00859882007665
• UDI-Public: 00859882007665
• 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: 04/10/2024

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: 731770
• Device Lot Number: 706881
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/10/2024
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other