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

Lot Number 180939

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/07/2018

Event Type  Injury  

Event Description

On (b)(6) 2018, customer (b)(6) reported discrepant (b)(6) results in the ultrio elite assay.The initial result was (b)(6) with subsequent ultrio elite results of (b)(6), then 2 more (b)(6).The customer routinely runs (b)(6) serology in parallel with the ultrio elite run and will retest discrepant results in both assays.The customer reported that their (b)(6) serology was (b)(6), but did not specify what (b)(6) serology testing was performed.Additionally, the results of further testing or investigation performed by the customer is not available and the donor sample was discarded.The investigation is completed for the discrepant (b)(6) results.A review of the quality control data for ultrio elite ml 180939 was performed and there were no related quality events found for this lot/batch of product and the product met all release criteria.The customer run reports did not show any issues with the instrument or the assay calibrators and internal control.The assay and instrument performed as expected.The root cause is most likely a low (b)(6) titer sample as the ultrio elite results were inconsistently (b)(6) and the customer reported (b)(6) serology (b)(6).The ultrio elite master lot as well as the individual components passed all qc release specifications.The customer run did not show any issues with the validity of calibrators or external control performance.Sporadically (b)(6) ultrio elite results support the donor sample having a low (b)(6) titer.

Event Description

On (b)(6) 2018, customer (b)(6) reported discrepant hbv results in the ultrio elite assay.The initial result was nonreactive (s/co of 0.20) with subsequent ultrio elite results of nonreactive (s/co 0.09), then 2 more reactive results (s/cos 13.43 and 12.84).The customer routinely runs hbv serology in parallel with the ultrio elite run and will retest discrepant results in both assays.The customer reported that their hbv serology was reactive for hbv, but did not specify what hbv serology testing was performed.Additionally, the results of further testing or investigation performed by the customer is not available and the donor sample was discarded.The investigation is completed for the discrepant hbv results.A review of the quality control data for ultrio elite ml 180939 was performed and there were no related quality events found for this lot/batch of product and the product met all release criteria.The customer run reports did not show any issues with the instrument or the assay calibrators and internal control.The assay and instrument performed as expected.The root cause is most likely a low hbv titer sample as the ultrio elite results were inconsistently reactive and the customer reported hbv serology positive.The ultrio elite master lot as well as the individual components passed all qc release specifications.The customer run did not show any issues with the validity of calibrators or external control performance.Sporadically reactive ultrio elite results support the donor sample having a low hbv titer.Follow-up report 12aug2019: no further information has been received, this is considered the final report.

• Brand Name: PROCLEIX ULTRIO ELITE ASSY
• Type of Device: HIV-1/HIV-2/HCV/HBV DEVICE
• Manufacturer (Section D): GRIFOLS DIAGNOSTIC SOLUTIONS INC.; 4560 horton street; emeryville CA 94608
• MDR Report Key: 8436534
• MDR Text Key: 139545341
• Report Number: 2032600-2019-00003
• 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: 08/13/2019

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: 180939
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/07/2018
• Initial Date FDA Received: 03/20/2019
• Supplement Dates Manufacturer Received: 06/07/2018
• Supplement Dates FDA Received: 08/13/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Other