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

Lot Number 702056

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

Patient Problem Test Result (2695)

Event Date 07/06/2020

Event Type  Injury  

Event Description

On 08oct2020, grifols customer, (b)(6) in (b)(6), reported a discrepant (b)(6) result between serology and the procleix ultrio plus assay. The customer had a donation that was (b)(6), anti-(b)(6), and anti-(b)(6) but the pool of 16 that it was tested in was nonreactive when tested with procleix ultrio plus ml 702056. Testing took place in (b)(6) 2020. At the time of reporting to grifols, (b)(6) had not analyzed this donation individually on ultrio plus, or other nat methods. The customer confirmed that the donation was rejected for use as it is standard practice for them to reject donations that are serology (b)(6). The other 15 samples in the pool were serology (b)(6) and were released. (b)(6) will perform additional testing for the individual donation using procleix ultrio plus, and procleix ultrio elite assays during the week of (b)(6) 2020, and provide that information to grifols when available. The site will also be sending back sample to grifols for additional testing. Grifols will send the samples to a reference lab for (b)(6) quantitative testing. Grifols qa performed a previous events search of similar complaints and reviewed the qc release data for procleix ultrio plus ml702056. Review of the qc release data, and a previous events search in the grifols complaint system indicate that the assay is working as designed. Follow-up information for this report will be provided as necessary.

• Brand Name: PROCLEIX ULTRIO PLUS ASSAY
• Type of Device: HIV-1/HCV/HBV DEVICE
• Manufacturer (Section D): GRIFOLS DIAGNOSTIC SOLUTIONS INC.; 4560 horton street; emeryville CA 94608
• Manufacturer Contact: richa padhya ; 10808 willow court; san diego, ca ; 2020826
• MDR Report Key: 10788944
• MDR Text Key: 216831697
• Report Number: 2032600-2020-00005
• Device Sequence Number: 1
• Product Code: QHO
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: BL 125113
• 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,Followup
• Report Date: 02/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Lot Number: 702056
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/08/2020
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No Answer Provided
• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage

Patient Treatment Data

Date Received: 11/04/2020 Patient Sequence Number: 1