MAUDE Adverse Event Report: GRIFOLS DIAGNOSTIC SOLUTIONS INC. PROCLEIX ULTRIO ASSAY; HIV-1, HCV AND/OR HBV IVD DEVICE

Catalog Number 301105

Device Problem False Negative Result (1225)

Patient Problem No Code Available (3191)

Event Date 07/31/2017

Event Type  Injury  

Manufacturer Narrative

This initial mdr event was submitted under report number 2024800-2017-00020 on october 27, 2017.Due to the duplicate report number, this emdr submission failed and is being resubmitted under a different (2032600-2017-00001) report number as recommended by cdrh emdr consumer safety officer.

Event Description

Complaint was received by grifols from (b)(6) located in (b)(6) on 28sep2017 regarding a case of a (b)(6) result generated during (b)(6) 2017 draw testing, which was screened (b)(6) using the procleix ultrio assay on the tigris system.Based on the reported incident and available information to date, the donor was (b)(6) in (b)(6) 2017 (approximate).

Event Description

Complaint was received by grifols from efs (french blood establishment) located in (b)(6) on (b)(6) 2017 regarding a case of a false negative result generated during (b)(6) 2017 draw testing, which was screened nonreactive using the procleix ultrio assay on the tigris system.Based on the reported incident and available information to date, the donor was positive for hiv-1 in (b)(6) 2017 (approximate).There is no additional information of potential transmission-transfusion due to this incident.Grifols is waiting for information about the status of the recipients (if any) from the (b)(6) 2017 donation.No corrective actions are required for the procleix ultrio assay.The investigation and data show that the assay is performing as intended.(b)(6) 2020: this report is a resubmission of a previous report, 2032600-2017-00002 follow-up 2, that was inadvertantly submitted as the wrong mdr number on (b)(6) 2017.It is being resubmitted as 2032600-2017-00001 follow-up 2 per request by fda on (b)(6) 2020.

Event Description

Complaint was received by grifols from efs (french blood establishment) located in epagny-metz-tessy, france on (b)(6)2017 regarding a case of a false negative result generated during (b)(6) 2017 draw testing, which was screened nonreactive using the procleix ultrio assay on the tigris system.Based on the reported incident and available information to date, the donor was positive for hiv-1 in (b)(6) 2017 (approximate).No information regarding recipient(s) of the march donation or the health outcome of these recipient(s) has been provided to grifols.Multiple attempts have been made to acquire this information, but the requests for information have been denied.No corrective actions are required for the procleix ultrio assay.The investigation and data show that the assay is performing as intended.(b)(6)2020: this report is an update to the previous report, 2032600-2017-00001 follow-up 2, that was missing updated information in section b5.It is being resubmitted as 2032600-2017-00001 follow-up 3 with updated narrative in section b5.

Event Description

Complaint was received by grifols from efs (french blood establishment) located in (b)(6) , france on 28sep2017 regarding a case of a false negative result generated during (b)(6) 2017 draw testing, which was screened nonreactive using the procleix ultrio assay on the tigris system.Based on the reported incident and available information to date, the donor was positive for hiv-1 in (b)(6) 2017 (approximate).There is no additional information of potential transmission-transfusion due to this incident.Grifols is waiting for information about the status of the recipients (if any) from the (b)(6) 2017 donation.No corrective actions are required for the procleix ultrio assay.The investigation and data show that the assay is performing as intended.07/21/2020: this report is a resubmission of a previous report, 2032600-2017-00002 follow-up 1, that was inadvertantly submitted as the wrong mdr number on 06-dec-17.It is being resubmitted as 2032600-2017-00001 follow-up 1 per request by fda on 16-jul-20.

• Brand Name: PROCLEIX ULTRIO ASSAY
• Type of Device: HIV-1, HCV AND/OR HBV IVD DEVICE
• Manufacturer (Section D): GRIFOLS DIAGNOSTIC SOLUTIONS INC.; 4560 horton street; emeryville, ca CA 92121
• MDR Report Key: 7076964
• MDR Text Key: 93558572
• Report Number: 2032600-2017-00001
• Device Sequence Number: 1
• Product Code: QHO
• Combination Product (y/n): N
• PMA/PMN Number: BL125113
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 301105
• Device Lot Number: 176126
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/28/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other