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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
Lot Number 703038
Device Problem Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problem Insufficient Information (4580)
Event Date 04/28/2021
Event Type  Injury  
Event Description
On (b)(6) 2021, grifols customer, (b)(6), reported discordant (b)(6) results between serology and testing on the procleix ultrio elite assay for one donor sample. Blood bank (b)(6) tested the donation on (b)(6) 2021. The sample gave a (b)(6) result on the ultrio elite screening assay (ml 703038) but was (b)(6) using an abbott serology test. The sample was sent to (b)(6) for additional testing. It was tested with a roche pcr test and a roche serology test and gave the following results: (b)(6). Blood bank (b)(6) used the plasma bag from the donor to perform additional ultrio elite testing. On (b)(6) 2021, 5 replicates were tested using the ultrio eilte screening assay (ml 703038). All results were (b)(6). They also tested 1 replicate on (b)(6) 2021 using the ultrio elite dhbv assay (ml 703038) which gave a result of (b)(6). (b)(6) performed additional testing on the original sample they received using the ultrio elite (b)(6) assay (ml 702894) on (b)(6) 2021. Two replicates were tested and both gave (b)(6) results. The sample and the donor have been blocked. The donation was not released. The customer is currently arranging shipment of material from the plasma bag to grifols for investigational testing. Grifols will arrange for (b)(6) quantitative testing of the material once received. Current expected date of receipt of the material at grifols is pending an update from the customer. Review of all related run reports from blood bank (b)(6) and (b)(6) was completed. Calibrator results and internal control values were reviewed. There is no indication of any amplification issues or general problems with the runs performed. Review of the device history record (dhr) for procleix ultrio elite ml 703038 was performed. Dhr review confirmed that the master lot performed as expected and met all qc release specificity and sensitivity criteria. A review of grifols complaint records created for ultrio elite (b)(6) sensitivity issues from 3 years prior to the occurrence date through the present was completed. There is no complaint information that indicates an (b)(6) sensitivity problem with ultrio elite ml 703038 or the ultrio elite assay in general. An update to this report will be filed when the investigation is completed.
 
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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 ct
san diego, CA 92127
8582020852
MDR Report Key12125246
MDR Text Key267121086
Report Number2032600-2021-00003
Device Sequence Number1
Product Code QHO
Combination Product (y/n)N
Reporter Country CodePL
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 08/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/06/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Lot Number703038
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/08/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 07/06/2021 Patient Sequence Number: 1
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