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

Lot Number 704542

Device Problem False Negative Result (1225)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/31/2022

Event Type  Injury  

Event Description

On (b)(6) 2022, grifols customer gift of hope (united states of america) reported getting discordant results between serology and the procleix ultrio elite assay for a beating heart organ donor.Hiv results for both serology (abbott alinity anti-hcv) and procleix ultrio elite screening and dhiv assay results were nonreactive.Hbv and hcv results were discordant, giving the following results: abbott alinity anti-hbc: reactive, abbott alinity hbsag: nonreactive, abbott alinity anti-hcv: reactive, procleix ultrio elite screening: nonreactive in duplicate, ultrio elite dhbv: reactive in duplicate, ultrio elite dhcv: nonreactive in duplicate.The same procleix panther instrument and ultrio elite (ml 704542) were used for all procleix ultrio elite testing.The customer declined to provide any information from the donor questionnaire, citing confidentiality.The organs from this donor were flagged as known hcv/hbv infected status and were used for transplant in accordance with the testing sites operating procedures.Grifols is investigating the discordant hbv results between ultrio elite screening (nonreactive) and serology (reactive) and ultrio elite dhbv (reactive), as well as the discordant hcv results for ultrio elite screening (nonreactive) and dhcv (nonreactive) compared to serology (reactive).The sample tubes used for procleix (k2edta) and serology (preservative and coagulant free) testing were collected at the same time.Grifols reviewed customer reagent and storage and preparation and did not find anything unusual.The ultrio elite run reports from the customer site were reviewed.There were no instrument errors.The runs were normal and valid.Calibrators were valid with no unusual values.Internal control results for the sample on all runs did not indicate any issues with amplification.Review of the device history record (dhr) for ultrio elite ml 704542 was completed.Dhr review confirmed that the master lot performed as expected and met all qc release sensitivity and specificity criteria for both screening and discriminatory assays.A review of grifols complaint records created for ultrio elite hbv and hcv sensitivity issues for one year prior to the occurrence date through the present was completed.There is no complaint information that indicates and hbv or hcv sensitivity problem with ultrio elite ml 704542 or with the ultrio elite assay in general.An investigation into the root cause of the discordant hbv and hcv results is ongoing.The customer had sample available for investigational testing at grifols.Sample was delivered to grifols on (b)(6) 2022 and investigational testing is in progress.An update to this report will be filed with results of the investigational testing once completed.

Event Description

I on (b)(6) 2022, grifols customer gift of hope (united states of america) reported getting discordant results between serology and the procleix ultrio elite assay for a beating heart organ donor.Hiv results for both serology (abbott alinity anti-hcv) and procleix ultrio elite screening and dhiv assay results were nonreactive.Hbv and hcv results were discordant, giving the following results: abbott alinity anti-hbc: reactive abbott alinity hbsag: nonreactive abbott alinity anti-hcv: reactive procleix ultrio elite screening: nonreactive in duplicate ultrio elite dhbv: reactive in duplicate ultrio elite dhcv: nonreactive in duplicate the same procleix panther instrument and ultrio elite (ml 704542) were used for all procleix ultrio elite testing.The customer declined to provide any information from the donor questionnaire, citing confidentiality.The organs from this donor were flagged as known hcv/hbv infected status and were used for transplant in accordance with the testing sites operating procedures.Grifols is investigating the discordant hbv results between ultrio elite screening (nonreactive) and serology (reactive) and ultrio elite dhbv (reactive), as well as the discordant hcv results for ultrio elite screening (nonreactive) and dhcv (nonreactive) compared to serology (reactive).The sample tubes used for procleix (k2edta) and serology (preservative and coagulant free) testing were collected at the same time.Grifols reviewed customer reagent and storage and preparation and did not find anything unusual.The ultrio elite run reports from the customer site were reviewed.There were no instrument errors.The runs were normal and valid.Calibrators were valid with no unusual values.Internal control results for the sample on all runs did not indicate any issues with amplification.Review of the device history record (dhr) for ultrio elite ml 704542 was completed.Dhr review confirmed that the master lot performed as expected and met all qc release sensitivity and specificity criteria for both screening and discriminatory assays.A review of grifols complaint records created for ultrio elite hbv and hcv sensitivity issues for one year prior to the occurrence date through the present was completed.There is no complaint information that indicates and hbv or hcv sensitivity problem with ultrio elite ml 704542 or with the ultrio elite assay in general.An investigation into the root cause of the discordant hbv and hcv results is ongoing.The customer had sample available for investigational testing at grifols.Sample was delivered to grifols on 06oct2022 and investigational testing is in progress.An update to this report will be filed with results of the investigational testing once completed.Final report: the customer provided the donor plasma sample to grifols for investigational testing on (b)(6) 2022.Hbv and hcv quantitative testing was completed on (b)(6) 2022.Investigational testing was performed by testing the sample using the hologic aptima hbv quant assay (aptima qhbv) and hologic aptima hcv quant dx assay (aptima qhcv).The testing result for both assays was "not detected".Per the aptima qhbv package insert (aw-15644, rev.002), the limit of detection (lod) of the assay using the 3rd who international standard for hbv dba (nibsc 10/264, genotype a) is 4.8 iu/ml for plasma and 5.9 iu/ml for serum.Based on the aptima qhbv "not detected" result and the lod indicated in the aptima qhbv package insert, if hbv is present in the plasma sample it is at a concentration below 4.8 iu/ml.The ultrio elite package insert (gdss-ifu-000006 v7.0) shows 95% detection probability of 4.3 iu/ml with 95% fiducial limits of 3.8 - 5.0 iu/ml for the hbv who (97/750) international standard on the ultrio elite screening assay and 4.5 iu/ml with 95% fiducial limits of 4.0 - 5.0 iu/ml on the ultrio elite dhbv assay.Based on the results of hbv quantitative testing, the hbv concentration of the sample is at or below the ultrio elite screening and dhbv lods for hbv and therefore would not be expected to give consistently reactive results.The root cause of the nonreactive ultrio elite screening result is low titer sample and the ultrio elite assay is performing as designed.Per the aptima qhcv package insert (aw-14498, rev.002), the lod of the assay using the 2rd who international standard for hcv rna (bibsc 96/798, genotype 1) is 3.9 iu/ml for plasma and 3.4 iu/ml for serum.Based on the aptima qhbv "not detected" result and the lod indicated in the aptima qhcv package insert, if hcv is present in the plasma sample it is at a concentration below 3.9 iu/ml.The ultrio elite package insert (gdss-ifu-000006 v7.0) shows 95% detection probability of 3.0 iu/ml with 95% fiducial limits of 2.5 - 3.9 iu/ml for the hcv who (06/100) international standard on the ultrio elite screening assay and 2.4 iu/ml with 95% fiducial limits of 2.0 - 3.3 iu/ml on the ultrio elite dhcv assay.Based on the results of hcv quantitative testing, the hcv concentration of the sample is at or below the ultrio elite screening and dhcv lods for hcv and therefore would not be expected to give consistently reactive results.The root cause of the nonreactive ultrio elite result is low titer sample and the ultrio elite assay is performing as designed.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: 15557663
• MDR Text Key: 301326407
• Report Number: 2032600-2022-00006
• Device Sequence Number: 1
• Product Code: QHO
• UDI-Device Identifier: 00859882007603
• UDI-Public: 00859882007603
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BL125652
• 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,Followup
• Report Date: 11/04/2022

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: Health Professional
• Device Lot Number: 704542
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/09/2022
• Initial Date FDA Received: 10/06/2022
• Supplement Dates Manufacturer Received: 09/09/2022
• Supplement Dates FDA Received: 11/04/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other