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

Lot Number 700516

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Test Result (2695)

Event Date 07/12/2019

Event Type  Injury  

Event Description

On 12jul2019, grifols customer (b)(6) reported discrepant hbv results between the ultrio elite assay and the hbv elisa hbsag assay.A donor sample was nonreactive upon initial ultrio elite testing (s/co of 0.08) and reactive with the hbv elisa hbsag by both diasorin and xinchuang methods.Repeat testing was nonreactive in ultrio elite and reactive in the ultrio elite discriminatory hbv assay.All samples were tested individually.The donor unit was discarded.A review of batch records for ultrio elite master lot (ml) number 700516 showed that the lot passed all qc release specifications.There are no nonconformances for this ml and any of the related components.This event was identified as a reportable event beyond reporting timelines and is being reported as soon as identified.An investigation is in-progress, any additional information received will be provided in a follow-up report.

Event Description

On (b)(6) 2019, grifols customer sichuan ziyang blood cente in ziyang, china reported discrepant hbv results between the ultrio elite assay and the hbv elisa hbsag assay.A donor sample was nonreactive upon initial ultrio elite testing (s/co of 0.08) and reactive with the hbv elisa hbsag by both diasorin and xinchuang methods.Repeat testing was nonreactive in ultrio elite and reactive in the ultrio elite discriminatory hbv assay.All samples were tested individually.The donor unit was discarded.A review of batch records for ultrio elite master lot (ml) number 700516 showed that the lot passed all qc release specifications.There are no nonconformance's for this ml and any of the related components.This event was identified as a reportable event beyond reporting timelines and is being reported as soon as identified.An investigation is in-progress, any additional information received will be provided in a follow-up report.Follow up information (final): the customer provided additional ultrio elite run reports which included the initial ultrio elite s/co result of 0.08, the follow-up ultrio elite s/co result of 0.16 and the ultrio elite discriminatory hbv s/co result of 13.84.The customer run reports did not show any issues and the customer did not report any issues with the testing performed or the instrument.This sample was from a known hbv positive donor.A review of the package insert indicates that below 15 iu/ml for hbv reactivity drops below 100%.The root cause is most likely a sample that has a low hbv titer.The low reactive rate in the ultrio elite assay as well as reactive hbsag serology by two methods supports this conclusion.The master lot as well as the individual components passed all qc release specifications.The customer run data did not show any issues with validity or calibrators.The assay performed as expected.As this sample was from a known hbv positive donor and the ultrio elite reactive results were less than 100%, it supports that the donor sample has a low hbv titer.No further information is expected.This is considered the final report.

• Brand Name: PROCLEIX ULTRIO ELITE ASSAY
• Type of Device: HIV-1/HIV-2/HCV/HBV DEVICE
• Manufacturer (Section D): GRIFOLS DIAGNOSTICS SOLUTIONS INC.; 4560 horton street; emeryville CA 94608
• MDR Report Key: 9048480
• MDR Text Key: 162694913
• Report Number: 2032600-2019-00007
• Device Sequence Number: 1
• Product Code: MZF
• Combination Product (y/n): N
• PMA/PMN Number: BL125652
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 10/11/2019

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: No Information
• Device Lot Number: 700516
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/12/2019
• Initial Date FDA Received: 09/13/2019
• Supplement Dates Manufacturer Received: 07/12/2019
• Supplement Dates FDA Received: 10/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other