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

Lot Number 702238

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

Patient Problem Insufficient Information (4580)

Event Date 11/23/2020

Event Type  Injury  

Event Description

On (b)(6) 2021, grifols customer, (b)(6) in (b)(6), reported discordant (b)(6) results between serology and individual donor testing (idt) on the procleix ultrio elite assay.Initially, a pool of 16 (p16) tested (b)(6) on the ultrio elite assay (ml 702238).Pool constituents were tested individually using the same master lot of ultrio elite assay and all were (b)(6).Confirmatory testing of the pool constituents on the abbot prism found 1 donor to be (b)(6).The donation was not used for transfusion.Testing was completed in (b)(6) 2020.This issue was identified by the customer in (b)(6) 2021 after moving to a new qa system and the customer reported it to grifols at that time.The site did not have any sample to send to grifols for investigational testing.No additional information about the donor, such as (b)(6) infection or vaccine history, could be provided.Review of the device history record (dhr) for procleix ultrio elite ml 702238 was performed.Dhr review confirmed that the master lot performed as expected and met all qc release specificity and sensitivity criteria.A review of grifols complaint records created for ultrio elite hbv sensitivity issues from 12 months prior to the occurrence date through the present was completed.There is no complaint information that indicates an (b)(6) sensitivity problem with ultrio elite ml 702238 or the ultrio elite assay in general.The discordant results are consistent with results for a low titer sample where serology testing is (b)(6) but the viral load of the sample if not high enough to be consistently (b)(6) on the ultrio elite assay because the concentration does not meet the limit of detection of the assay.This could not be confirmed through quantitative testing of the sample as the customer did not have any available to return to grifols for investigation.Due to the lack of sample for investigational testing and the lack of additional information, the root cause of the results at the customer site could not be determined.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 DIAGNOSTIC SOLUTIONS INC.; 4560 horton street; emeryville CA 94608
• Manufacturer Contact: amanda doe ; 10808 willow court; san diego, CA 92127 ; 8582020852
• MDR Report Key: 11499604
• MDR Text Key: 252966974
• Report Number: 2032600-2021-00001
• Device Sequence Number: 1
• Product Code: QHO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BL 125652
• 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: 03/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Lot Number: 702238
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/17/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other