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U.S. Department of Health and Human Services

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

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GRIFOLS DIAGNOSTIC SOLUTIONS INC. PROCLEIX ULTRIO ELITE ASSAY HIV-1/HIV-2/HCV/HBV DEVICE Back to Search Results
Catalog Number 9051171
Device Problem Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/07/2022
Event Type  Injury  
Event Description
On (b)(6) 2022, grifols customer plasma lab s. R. O. ((b)(6)) reported discrepant (b)(6) results between procleix ultrio elite assay and abbott alinity s anti-hcv in an individually tested plasma donation. The sample was simultaneously positive in serology testing ((b)(6)) and (b)(6) in the ultrio elite assay. The sample was quarantined to prevent release for fractionation and sent to the (b)(6) for supplemental testing. Additional serology testing confirmed the sample is positive for (b)(6) antibodies. Based on the initial serology testing performed by the customer and supplemental testing performed by (b)(6), the customer considers the (b)(6) ultrio elite result a (b)(6). Additional pcr testing from (b)(6) for (b)(6) rna is pending. Testing results are summarized below. Initial testing for sample (b)(6): ultrio elite (b)(6) (s/co (b)(6)) and abbott alinity s (b)(6) in 3 replicates (s/cos (b)(6)). Supplemental testing: architect (b)(6) (s/co (b)(6)), biorad (b)(6) (s/co (b)(6)), ortho (b)(6) (s/co (b)(6)). Pending testing: (b)(6) rna pcr (roche hcv taqman). The ultrio elite run report and raw data were reviewed for the run performed. No errors or chemistry issues were observed that might contribute to (b)(6) results. The reagent qc release data for ultrio elite master lot ml 703564 was reviewed and there were no indications of a problem with hcv sensitivity. The master lot passed all sensitivity specifications for (b)(6), in addition to all other analytes and specifications. Manufacturing quality notifications (qns) were reviewed. None were identified as possible contributors to low hcv sensitivity in the ultrio elite assay. The procleix ultrio elite package insert (503049en rev. 005) shows hcv who (06/100) international standard 95% detection probability of 3. 0 iu/ml with 95% fiducial limits of 2. 5 to 3. 9 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. An investigation is ongoing, this report will be updated when the supplemental pcr results are available from nrl.
 
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Brand NamePROCLEIX ULTRIO ELITE ASSAY
Type of DeviceHIV-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 Key13443059
MDR Text Key289540280
Report Number2032600-2022-00001
Device Sequence Number1
Product Code QHO
Combination Product (y/n)N
Reporter Country CodeEZ
PMA/PMN Number
BL125652
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/02/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/03/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number9051171
Device Lot Number703564
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/07/2022
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 02/03/2022 Patient Sequence Number: 1
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