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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 716273
Device Problem False Negative Result (1225)
Patient Problem Insufficient Information (4580)
Event Date 02/12/2022
Event Type  Injury  
Event Description
On (b)(6) 2022, (b)(6) hospital ((b)(6)) reported four (b)(6), (b)(6) samples that were nonreactive in the procleix ultrio elite discriminatory (b)(6) master lot (ml) 703890. The four samples were also tested in (b)(6), and each had hcv titer greater than equal to 35 iu/ml (above the 2. 4 iu/ml lod of the ue (b)(6)). No remaining sample volume is available for investigation and there is no option for a new blood draw. No customer information is available at this time. Samples and donors were blocked from use. Though reported to grifols on (b)(6 )2022, the complaint work order was not created until (b)(6) 2022. During qa review of the work order, the complaint was reclassified as potential health and safety complaints" and later the product quality committee determined this event was mdr reportable. Investigation into this delay is ongoing. An investigation is ongoing to determine the root cause for these nonreactive results in the ultrio elite (b)(6) assay. The customer is using the discriminatory assays to confirm positive serology results, rather than initially screening with the ultrio elite multiplex assay and testing samples with reactive results in the discriminatory assays per the package insert. A review of the quality control data for ultrio elite ml 703890 was performed. There were no related quality events found for this lot/batch of product and the product met all release criteria, and no additional complaints have been reported for this type of error in the dhcv assay for ml 703890 or any other master lot over the last year. Details for sample handling/ storage and other testing performed have been requested. Preliminary conclusion: specimen handling and storage has not been ruled out as the root cause for the nonreactive dhcv results. The previous events search, and qc release data do not indicate an hcv sensitivity issue with the ue (b)(6) assay. Instructions in the package insert regarding discriminatory testing (initially screening with the ultrio elite multiplex assay and testing samples with reactive results in the discriminatory assays) were not followed by the customer. Since there are 4 different donors, each donor has its own mdr. See section b6 for further information. Follow-up information for this report will be provided when available.
 
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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 Key14163728
MDR Text Key289732827
Report Number2032600-2022-00005
Device Sequence Number1
Product Code QHO
Combination Product (y/n)N
Reporter Country CodePK
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
Report Date 04/20/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/20/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number716273
Device Lot Number703890
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 04/20/2022 Patient Sequence Number: 1
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