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

Lot Number 702733 AND 703038

Device Problem False Negative Result (1225)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/12/2021

Event Type  Injury  

Event Description

On (b)(6) 2021, grifols distributor ilex biotech ltd (b)(4) reported a procleix ultrio elite assay false negative result in a blood donation.Reactive results from a july donation triggered additional testing on archived samples from the donor's previous donations in (b)(6) 2021 and (b)(6) 2020.The additional testing (dhbv reactive for march donation and anti-hbc positive for both december and march donations) was discordant with the initial negative interpretations for those donations (ue nonreactive and hbsag negative).Based on the additional testing performed in (b)(6), the customer considers the nonreactive ultrio elite results from december and march to be false negatives.The december donation was transfused into a patient.The recipient self-reported as healthy with no clinical data provided.The march donation was released to a plasma fractionation center and use beyond that is unknown.The july donation was not released.No additional information was available about the condition of the donor.Testing results from each donation are summarized below.Donation (b)(6) 2021: initial testing was reactive in ultrio elite and dhbv (s/cos 13.73 and 22.76) and anti-hbc positive.A second aliquot from the same donation was tested in ultrio elite and dhbv and was nonreactive (s/cos 0.07 and 0.02).Donation (b)(6) 2021: initial testing was nonreactive in ultrio elite and hbsag negative.The archived donation was tested in july in dhbv (reactive, s/co 23.48) and anti-hbc (positive).Donation (b)(6) 2020: initial testing was nonreactive in ultrio elite and hbsag negative.The archived donation was tested in july in dhbv (nonreactive) and anti-hbc (positive).The reagent qc release data for the two reagent master lots (ml 702733 and 703738) used were reviewed and there were no indications of a problem with hbv sensitivity.The master lots passed all sensitivity specifications for hbv in addition to all other analytes and specifications.The procleix ultrio elite package insert (503049en rev.005) shows hbv who (97/750) international standard 95% detection probability of 4.3 iu/ml with 95% fiducial limits of 3.8-5.0 iu/ml for the ultrio elite screening assay.A sample below the limit of detection of the assay would be expected to give nonreactive or intermittently reactive results.The customer provided additional testing including quantitation of the three donations and additional replicate testing of the july donation in ultrio elite and dhbv.Hbv quantitation (aptima quant hbv) was performed in singlet on the three donations made in december, march, and july.All results were "not detected".The quantification range for the aptima quant hbv assay is 10 to 1,000,000,000 iu/ml hbv.The additional ultrio elite testing on the july donation showed intermittent reactivity.The sample was reactive in 4/10 replicates on one instrument and reactive in 4/9 replicates on a second instrument tested with the ultrio elite screening assay.Sixteen replicates were also tested in dhbv, with 9/16 reactive.Actual concentration of the sample could not be determined because hbv dna was not detected in the quantitative assay used for investigational testing.The intermittent reactivity on the ultrio elite screening and dhbv assays and the serology results indicate that hbv was present in the sample but was below the limit of detection of the ultrio elite assay.No further information is expected.This is the final report.

• Brand Name: PROCLEIX ULTRIO ELITE ASSAY
• Type of Device: HIV-1/HIV-2/HCV/HBV DEVICE
• Manufacturer (Section D): GRIFOLS DIAGNOSTIC SOLUTIONS INC.; 4560 horton street; emeryville CA 94608
• Manufacturer Contact: amanda doe ; 10808 willow court; san diego, CA 92127 ; 8582020852
• MDR Report Key: 12338827
• MDR Text Key: 267224167
• Report Number: 2032600-2021-00004
• Device Sequence Number: 1
• Product Code: QHO
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: BL125652
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/18/2021

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: 702733 AND 703038
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/21/2021
• Initial Date FDA Received: 08/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other