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

Lot Number 700030

Device Problems False Negative Result (1225); Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 02/12/2019

Event Type  Injury  

Event Description

On 10mar2019, grifols customer blood assurance reported differing hiv-1 results between a master pool (mp) of 16 donors and an individual donor that was tested with the procleix ultrio plus assay.The mp was tested in a single replicate in ultrio plus master lot 700030 on the tigris instrument and the result was (b)(6).One individual component of the mp was (b)(6) on prism anti-hiv1/2 assay.That individual component was also (b)(6) for confirmatory western blot.An alternate sample from the frozen plasma unit of the same individual donor was tested in ultrio plus and hiv-1, hcv and hbv discriminatory assays.It was (b)(6) in ultrio plus and dhiv assays, and (b)(6) in dhcv and dhbv assays.This alternate sample was also (b)(6) in the western blot.The customer considers the ultrio plus (b)(6) result for the mp a "(b)(6)".Customer data is listed below.Unit # (b)(6) was added to master pool (b)(6) on (b)(6) /2019.(b)(6) was tested with ultrio plus on tigris instrument (b)(4) on (b)(6) 2019, (b)(6).(b)(6) was tested with prism anti-hiv1/2 assay, (b)(6) results.(b)(6) was sent for confirmatory western blot testing, (b)(6) confirmatory results.Alternate samples were tested from the frozen plasma unit associated with unit # (b)(6) under non-donor # (b)(6).Ultrio plus: (b)(6).Dhiv: (b)(6).Dhbv: (b)(6).Dhcv: (b)(6).The unit was not released for use based on results obtained.An investigation was completed.A review of the quality control data for ultrio plus ml 700030 was performed.There were no related quality events found for this lot of product and the product met all release criteria.Remaining sample from the individual donor plasma was sent to gds.It was then tested in the aptima hiv-1 quant assay.(b)(6) was detected in the specimen, but it was at a titer below the limit of quantification of the assay (below 30 copies/ml (b)(6)).Based on the customer data and the investigational data, the ultrio plus assay and tigris instrument performed as expected.The individual donor had a (b)(6).Dilution of the individual donor into a pool of 16 caused the titer of the pool specimen to be below the limit of detection of the ultrio plus assay.No further information is expected.This is considered the final report.

• Brand Name: PROCLEIX ULTRIO PLUS ASSAY
• Type of Device: HIV-1/HCV/HBV DEVICE
• Manufacturer (Section D): GRIFOLS DIAGNOSTIC SOLUTIONS INC.; usa; 4560 horton street; emeryville CA 94608
• Manufacturer Contact: amanda doe ; 10808 willow court; san diego, CA 92127 ; 8582020852
• MDR Report Key: 8489609
• MDR Text Key: 141184104
• Report Number: 2032600-2019-00005
• Device Sequence Number: 1
• Product Code: MZF
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 04/05/2019

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: 700030
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/10/2019
• Initial Date FDA Received: 04/05/2019
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other