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

Lot Number 701857

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

Patient Problem Test Result (2695)

Event Date 12/08/2019

Event Type  Injury  

Event Description

On 08dec2019, grifols customer (b)(6) red cross lifeblood in (b)(6) reported that a donor sample from a potential tissue donor was nonreactive in ultrio plus (s/co 0.68) but reactive in the discriminatory hcv assay (s/co 7.71) on the same run.The customer reported that the donor was confirmed (b)(6) in 2013.All samples were tested individually.It is unknown at this time if the tissue donation was discarded.The batch record for the ultrio plus master lot (ml) number 701857 used was reviewed and indicated that the lot met all qc release specifications.There were no similar issues reported to date with this lot number.An investigation is ongoing for the (b)(6) results.Follow-up information for this report will be provided when available.

Event Description

On (b)(6) 2019, grifols customer (b)(6),reported that a donor sample from a potential tissue donor was nonreactive in procleix ultrio plus (s/co 0.68) but reactive in the discriminatory hcv assay (s/co 7.71) on the same run.The customer reported that the donor was confirmed hcv positive in 2013.All samples were tested individually.It is unknown at this time if the tissue donation was discarded.The batch record for the procleix ultrio plus master lot (ml) number 701857 used was reviewed and indicated that the lot met all qc release specifications.There were no similar issues reported to date with this lot number.An investigation is ongoing for the discrepant hcv results.Follow-up information for this report will be provided when available.Final information: the investigation is complete for the procleix ultrio plus hcv discrepant results from a potential organ donor, initially reported as "tissue donor".The organ transplant was cancelled for unknown reasons prior to obtaining the discrepant procleix ultrio plus hcv results.The customer sent the sample to another reference laboratory for additional confirmatory testing.The sample was tested with a roche mpx qualitative assay which yielded a negative hcv result.The most probable root cause of the discrepant results is a low titer hcv sample.The donor history as well as the hcv discriminatory reactive result and the negative result in the confirmatory qualitative assay in another method, is consistent with this root cause.The procleix ultrio plus assay performed as expected.No further information or data is expected, this is considered the final report.

Event Description

On (b)(6) 2019, grifols customer australian (b)(6) in (b)(6), australia reported that a donor sample from a potential tissue donor was nonreactive in ultrio plus (s/co 0.68) but reactive in the discriminatory hcv assay (s/co 7.71) on the same run.The customer reported that the donor was confirmed hcv positive in 2013.All samples were tested individually.It is unknown at this time if the tissue donation was discarded.The batch record for the ultrio plus master lot (ml) number 701857 used was reviewed and indicated that the lot met all qc release specifications.There were no similar issues reported to date with this lot number.An investigation is ongoing for the discrepant hcv results.Follow-up information for this report will be provided when available.Final information: the investigation is complete for the procleix ultrio plus hcv discrepant results from a potential organ donor, initially reported as "tissue donor".The organ transplant was cancelled for unknown reasons prior to obtaining the discrepant procleix ultrio plus hcv results.The customer sent the sample to another reference laboratory for additional confirmatory testing.The sample was tested with a roche mpx qualitative assay which yielded a negative hcv result.The most probable root cause of the discrepant results is a low titer hcv sample.The donor history as well as the hcv discriminatory reactive result and the negative result in the confirmatory qualitative assay in another method, is consistent with this root cause.The procleix ultrio plus assay performed as expected.No further information or data is expected, this is considered the final report.On 06apr2020 grifols received fda feedback: "procleix ultrio plus assay contains an incorrect device product code.Specifically, the procode mzf is identified for your device under section d.2b of the report, although the correct product code for your device is qho." update to this report is only to modify the product code on section d.2b from mzf to qho.

• Brand Name: PROCLEIX ULTRIO PLUS ASSAY
• Type of Device: HIV-1/HCV/HBV DEVICE
• Manufacturer (Section D): GRIFOLS DIAGNOSTICS SOLUTIONS INC.; 4560 horton street; emeryville, ca CA 94608
• MDR Report Key: 9564074
• MDR Text Key: 189446028
• Report Number: 2032600-2019-00014
• 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: foreign
• Type of Report: Initial,Followup,Followup
• Report Date: 04/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Lot Number: 701857
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other