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

Lot Number 220154

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

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

Event Date 08/25/2018

Event Type  Injury  

Event Description

On (b)(6) 2018, grifols customer, (b)(6), reported that a sample (id (b)(6)) that was (b)(6) when tested on the procleix ultrio plus screening assay but was (b)(6) on the procleix ultrio plus discriminatory (b)(6) assay.The sample was also tested using the procleix ultrio plus discriminatory (b)(6) assays and was (b)(6) for both.The collection date of the sample was not initially provided and that information has been requested.(b)(6) reported that they typically run the discriminatory assays along with the screening sample, but another organ sample came in for testing unannounced for testing so for the sample (b)(6) the screening test and (b)(6) were run together and the (b)(6) tests were run with the 2nd organ donor sample that came in on a different tigris instrument.Testing results for sample (b)(6) were as follows: ultrio plus assay: testing date, worklist id/instrument: (b)(6) 2018, 103356/sn (b)(4), overall interpretation: (b)(6); ultrio plus (b)(6) assay: testing date, worklist id/instrument: (b)(6) 2018, 103357/sn (b)(4), overall interpretation: (b)(6); ultrio plus (b)(6) assay: testing date, worklist id/instrument: (b)(6) 2018, 108791/sn (b)(4), overall interpretation: (b)(6); ultrio plus (b)(6) assay: testing date, worklist id/instrument: (b)(6) 2018, 108792/sn (b)(4), overall interpretation: (b)(6).The sample is from a first time donor and (b)(6) reported that they will most likely not be able to get additional sample for testing from the donor.The customer requested that grifols review the data to confirm that the issue was not due to a problem with the instrument.On 28aug2018, a grifols field service engineer (fse) reviewed the worklists from the data of the testing to a month prior and found that rlu values were consistent and there were no other questionable results and the instrument is operating as intended.On 07sept2018 the fse performed another review of runs completed since the initial review and determined that there were no other questionable results and the instrument is operating as intended.An investigation into the (b)(6) screening results and (b)(6) result is ongoing.Remaining sample from the initial collection will be sent to the manufacturer for further evaluation.An evaluation of the quality control release data for ultrio plus ml 220154 has been performed.The product met all release criteria.Follow-up information for this report will be provided when available.

Event Description

On (b)(6) 2018, grifols customer, (b)(6) , reported that a sample (id (b)(6) ) that was nonreactive when tested on the procleix ultrio plus screening assay but was reactive on the procleix ultrio plus discriminatory hbv (dhbv) assay.The sample was also tested using the procleix ultrio plus discriminatory hiv (dhiv) and hcv (dhcv) assays and was nonreactive for both.The collection date of the sample was not initially provided and that information has been requested.Qualtex reported that they typically run the discriminatory assays along with the screening sample, but another organ sample came in for testing unannounced for testing so for the sample (b)(6) the screening test and dhcv were run together and the dhbv and dhiv tests were run with the 2nd organ donor sample that came in on a different tigris instrument.Testing results for sample (b)(6) were as follows: ultrio plus assay: testing date: worklist id/instrument: (b)(6) 2018, 103356/sn (b)(6).Overall interpretation: nonreactive.Ic rlu: 128,040.Analyte rlu: 7,210.S/co: 0.08.Ultrio plus dhcv assay: testing date: worklist id/instrument: (b)(6) 2018, 103357/sn (b)(6).Overall interpretation: nonreactive.Ic rlu: 139,167.Analyte rlu: 2,577.S/co: 0.04.Ultrio plus dhiv assay: testing date: worklist id/instrument: (b)(6) 2018, 108791/sn (b)(6).Overall interpretation: nonreactive.Ic rlu: 135,304.Analyte rlu: 2,085.S/co: 0.04.Ultrio plus dhbv assay: testing date: worklist id/instrument: (b)(6) 2018, 108792/sn (b)(6).Overall interpretation: reactive.Ic rlu: 148,633.Analyte rlu: 237,351.S/co: 4.22.The sample is from a first time donor and qualtex reported that they will most likely not be able to get additional sample for testing from the donor.The customer requested that grifols review the data to confirm that the issue was not due to a problem with the instrument.On (b)(6) 2018, a grifols field service engineer (fse) reviewed the worklists from the data of the testing to a month prior and found that rlu values were consistent and there were no other questionable results and the instrument is operating as intended.On 07sept2018 the fse performed another review of runs completed since the initial review and determined that there were no other questionable results and the instrument is operating as intended.An investigation into the nonreactive screening results and reactive dhbv result is ongoing.Remaining sample from the initial collection will be sent to the manufacturer for further evaluation.An evaluation of the quality control release data for ultrio plus ml 220154 has been performed.The product met all release criteria.Follow-up information for this report will be provided when available.Final report: review of the device history record (dhr) for procleix ultrio plus ml 220154 was performed.An hbv qc panel diluted to approximately 11 iu/ml is one of the samples used to release ultrio plus master lots.Dhr review confirmed that the master lot performed as expected and met all qc release sensitivity criteria.A review of grifols complaint records created for ultrio plus hbv sensitivity issues from 12 months prior to the complaint date as well as a review for all complaints related to ultrio plus ml 220154 was completed.Two additional ultrio plus sensitivity complaint were identified that could not be attributed to hardware or contamination issues.The root cause in both cases was determined to be low titer sample confirmed by hbv quantitative testing.For ultrio plus ml 220154, no other hbv results related issues were reported.There is no complaint information that indicates a problem with the ultrio plus assay or with ml 220154.Grifols quality requested that the sample be returned to grifols san diego for hbv quant testing but the sample was not provided.Information regarding additional testing, such as serology results, was requested but not provided.No additional information from the customer was provided.Review of the qc release data and a previous events search in the grifols complaint system indicate that the assay is working as designed.Although the results seen at the customer site are consistent with results seen for samples with an hbv concentration below the 100% limit of detection of the assay, this could not be confirmed as sample was not provided to grifols for quantitative testing.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.; 4560 horton street; emeryville, ca CA 92127
• MDR Report Key: 7920947
• MDR Text Key: 122159863
• Report Number: 2032600-2018-00004
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 07/30/2020

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: 220154
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/25/2018
• Initial Date FDA Received: 09/28/2018
• Supplement Dates Manufacturer Received: 08/25/2018
• Supplement Dates FDA Received: 07/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other