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

Lot Number 700005

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/13/2018

Event Type  Injury  

Event Description

On (b)(6) 2018, (b)(6) in (b)(6) reported a discrepant (b)(6) result for a donor sample (collected (b)(6) 2018) tested with procleix ultrio elite (ue) assay master lot (ml) 700005.The initial donor sample tested on (b)(6) 2018 yielded a (b)(6) result with an (b)(6).Additionally on (b)(6) 2018, (b)(6) quantitation was performed by (b)(6) test that had results of (b)(6).Serology tests performed on (b)(6) 2018 were (b)(6).The lab opted to retest two more replicates of the initial donation sample with ultrio elite assay on (b)(6) 2018 yielding (b)(6).Serology for (b)(6) was performed on (b)(6) 2018, which resulted in (b)(6) results for (b)(6) and a (b)(6) result for (b)(6).The lab performed additional testing from the plasma bag of this donor on (b)(6) 2018.The ue result was (b)(6), (b)(6) serology was (b)(6) and the (b)(6) quantitative test was (b)(6).The roche cobas (b)(6) quantitative test has a lower limit of detection of (b)(6), so this sample contains (b)(6).The customer indicated that there is no more sample left for further testing at their site or at (b)(6).The donor unit was discarded and there are no plans to collect more samples from this donor.An investigation is ongoing for the discrepant (b)(6) results.A review of the quality control data for ultrio elite ml 70005 was performed.There were no related quality events found for this lot/batch of product and the product met all release criteria.Follow-up information for this report will be provided when available.

Event Description

On 30dec2018, grifols customer, (b)(6) lab in saudi arabia, reported a discrepant hbv result for a donor sample (collected (b)(6) 2018) tested with procleix ultrio elite (ue) assay master lot (ml) 700005.The initial donor sample tested on (b)(6) 2018 yielded a nonreactive result with an s/co of 0.06.Additionally on 1(b)(6) 2018, hbv quantitation was performed by roche cobas test that had results of "not detected".Serology tests performed on (b)(6) 2018 were nonreactive (hiv ag/ab and anti-hcv).The lab opted to retest two more replicates of the initial donation sample with ultrio elite assay on (b)(6) 2018 yielding s/co values of 14.09 (reactive) and 0.17 (non-reactive).Serology for hbv (hbsag, anti-hbc and anti-hbs 3) was performed on (b)(6) 2018, which resulted in reactive results for hbsag and anti-hbc and a nonreactive result for anti-hbs 3.The lab performed additional testing from the plasma bag of this donor on (b)(6) 2018.The ue result was reactive (s/co 13.40), hbv serology was reactive (hbsag and anti-hbc) and the hbv quantitative test was "not detected".The roche cobas hbv quantitative test has a lower limit of detection of 20 iu/ml, so this sample contains less than 20 iu/ml hbv.The customer indicated that there is no more sample left for further testing at their site or at grifols.The donor unit was discarded and there are no plans to collect more samples from this donor.An investigation is ongoing for the discrepant hbv results.A review of the quality control data for ultrio elite ml 70005 was performed.There were no related quality events found for this lot/batch of product and the product met all release criteria.Follow-up information for this report will be provided when available.Folow up information (final): the investigation is complete for the discrepant hbv results.The customer run reports did not show any issues and the assay performed as expected.A review of the package insert indicates that below 15 iu/ml for hbv reactivity drops below 100%.The root cause is a low hbv titer sample.The master lot as well as the individual components passed all qc release specifications.The customer run did not show any issues with validity, calibrators or external control performance.Repeatedly reactive hbv serology, negative quantitative results and inconsistent ultrio elite results support the donor sample having a low hbv titer.Correction: the statement "additionally on (b)(6) 2018, hbv quantitation was performed by roche cobas test that had results of "not detected" " included within the original report should be removed as it was confirmed this testing was not completed on the date indicated.This is considered the final report, there is no additional information expected.

• 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
• MDR Report Key: 8287603
• MDR Text Key: 134629612
• Report Number: 2032600-2019-00002
• Device Sequence Number: 1
• Product Code: MZF
• Combination Product (y/n): N
• PMA/PMN Number: BL125652
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 02/13/2019

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: Health Professional
• Device Lot Number: 700005
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/30/2018
• Initial Date FDA Received: 01/29/2019
• Supplement Dates Manufacturer Received: 12/30/2018
• Supplement Dates FDA Received: 02/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other