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 Result or 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.

Event Description

On (b)(6) 2020, grifols customer, héma-québec in canada, reported a discrepant hbv results between serology and the procleix ultrio plus assay.The customer had a donation that was hbsag positive, anti-hbc positive, and anti-hbs positive but the pool of 16 that it was tested in was nonreactive when tested with procleix ultrio plus ml 702056.Testing took place in july 2020.At the time of reporting to grifols, héma-québec 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 positive.The other 15 samples in the pool were serology negative and were released.Héma-québec will perform additional testing for the individual donation using procleix ultrio plus and procleix ultrio elite assays during the week of 02nov2020 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 hbv quantitative testing.Additional information about donor have been requested but not yet provided.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.Follow up: héma-québec performed additional testing for the individual donation using procleix ultrio plus and procleix ultrio elite assays during the week of 02nov2020.Ten replicates of the donor sample were tested using ultrio plus on the tigris instrument.All 10 replicates were reactive.Ten replicates of the donor sample were tested using ultrio elite on the panther instrument.All 10 replicates were reactive.The customer also made master pool tubes of 16 using the donor sample and saline.When tested using ultrio plus on tigris, the 5 replicates gave 3 reactive and 2 nonreactive results.When tested using ultrio elite on panther, the 1 replicate tested was reactive.The customer sent the donor sample to grifols san diego for additional testing on (b)(6) 2020.Grifols sent the sample to the reference lab arup laboratories (salt lake city, utah) where it was tested for hepatitis b virus by quantitative naat.Hbv dna was detected in the sample but at a level below 10 iu/ml, which is the lower limit of quantitation of the assay used at arup.The procleix ultrio plus package insert (503786 rev.005) shows hbv who (97/750) international standard 95% detection probability of 3.4 iu/ml with 95% fiducial limits of 3.0- 4.1 iu/ml.Based on this information, the individual donor sample would need a concentration of about 50 iu/ml for the pool of 16 to be 95% reactive if all other samples had an hbv concentration of 0 iu/ml.The quantitative testing put the donor sample hbv concentration below 10 iu/ml.The results of the additional sample testing at the customer site and the quantitative testing of the donor sample confirm that the root cause of the discrepancy between the nonreactive pool of 16 result and the positive serology results is due to the hbv concentration of the donor sample.The hbv concentration is above the limit of detection of the ultrio plus assay when tested individually, but is too low to be consistently reactive when in a pool of 16 samples no further information is expected.This is 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 94608
• 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
• PMA/PMN Number: BL 125113
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health 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: No Information
• Device Lot Number: 702056
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other