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 03/19/2023

Event Type  Injury  

Event Description

On (b)(6) 2023, a representative for (b)(6) in kuwait reported discordant testing results between different testing methods for a plasma sample from a blood donor.Testing results are as follows: (b)(6) 2023: roche cobas hbv reactive, additional details pending.(b)(6) 2023: ultrio elite screening nr; s/co 0.10; rlu 10,515 with ml 704982.Serology was completed around the same time, but exact dates are pending: hbsag: negative.Anti-hbc: positive.The site noted that this is a known donor who was tested 6 or 7 months ago and was positive for anti-hbc and hbv nat at that time.Grifols has requested additional details re: which nat testing was performed at that time and the testing dates.The donation and donor have been blocked.The customer has 2ml of sample available for investigational testing at grifols.Grifols is currently arranging shipment of the material to grifols san diego for hbv quantitative testing.Delivery date of sample is pending.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 nr result for the sample in question and there were no instrument errors.The run reports for the non-grifols testing have been requested and receipt at grifols is pending.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, an occult infection, a false positive anti-hbc result (unlikely when taken in conjunction with the roche reactive result), or a mutant hbsag strain that is not detectable by laboratory assay.A resolved or occult infection would likely result in a low titer sample that is below the limit of detection of the ultrio elite assay.The actual concentration of the sample will be tested as part of the grifols complaint investigation.A review of the device history record (dhr) for ml 704982 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.The complaints previous events search and dhr review indicate the assay is working as designed.An update will be provided after completion of hbv quantitation testing for the donation sample.

Event Description

On 21mar2023, a representative for kuwait central blood bank in kuwait reported discordant testing results between different testing methods for a plasma sample from a blood donor.Testing results are as follows: (b)(6) 2023: roche cobas hbv reactive, additional details pending (b)(6) 2023: ultrio elite screening nr; s/co 0.10; rlu 10,515 with ml 704982 serology was completed around the same time, but exact dates are pending: hbsag: negative anti-hbc: positive the site noted that this is a known donor who was tested 6 or 7 months ago and was positive for anti-hbc and hbv nat at that time.Grifols has requested additional details re: which nat testing was performed at that time and the testing dates.The donation and donor have been blocked.The customer has 2ml of sample available for investigational testing at grifols.Grifols is currently arranging shipment of the material to grifols san diego for hbv quantitative testing.Delivery date of sample is pending.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 nr result for the sample in question and there were no instrument errors.The run reports for the non-grifols testing have been requested and receipt at grifols is pending.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, an occult infection, a false positive anti-hbc result (unlikely when taken in conjunction with the roche reactive result), or a mutant hbsag strain that is not detectable by laboratory assay.A resolved or occult infection would likely result in a low titer sample that is below the limit of detection of the ultrio elite assay.The actual concentration of the sample will be tested as part of the grifols complaint investigation.A review of the device history record (dhr) for ml 704982 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.The complaints previous events search and dhr review indicate the assay is working as designed.An update will be provided after completion of hbv quantitation testing for the donation sample.Updated information although the testing site initially indicated the sample would be available for investigational testing at grifols san diego, they ultimately declined to complete the required paperwork for shipment and the sample was not provided.The investigation was completed with the available information.Although the titer of the sample could not be confirmed through investigational hbv quantitative testing, the results are consistent with a sample at or below the lod of the ultrio elite assay.The roche cobas mpx has a lower hbv lod than the procleix ue assay so it would not be unexpected for a sample at or below the ue lod to be nonreactive on ue but be reactive for the roche cobas mpx assay if it has a concentration above the lod of the roche test.The serology results are consistent with a sample that could have a low hbv titer.The root cause of the nonreactive ultrio elite results could not be determined due to lack of sample for investigational testing.Although the sample could not be confirmed to be at or below the limit of detection of the ultrio elite assay, the serology results indicate that the donor likely had a resolved hbv infection or an occult hbv infection, both of which are characterized by low levels of hbv dna being present.Review of the qc release data and a previous events search in the grifols complaint system indicate that the assay is working as designed.No additional information 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: 16747996
• MDR Text Key: 313397084
• Report Number: 2032600-2023-00004
• Device Sequence Number: 1
• Product Code: QHO
• UDI-Device Identifier: 00859882007672
• UDI-Public: 00859882007672
• Combination Product (y/n): N
• Reporter Country Code: KU
• 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: 05/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/15/2023
• Device Catalogue Number: 731774
• Device Lot Number: 704982
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/21/2023
• 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