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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 702238
Device Problem Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problem Insufficient Information (4580)
Event Date 11/23/2020
Event Type  Injury  
Event Description
On (b)(6) 2021, grifols customer, (b)(6) in (b)(6), reported discordant (b)(6) results between serology and individual donor testing (idt) on the procleix ultrio elite assay. Initially, a pool of 16 (p16) tested (b)(6) on the ultrio elite assay (ml 702238). Pool constituents were tested individually using the same master lot of ultrio elite assay and all were (b)(6). Confirmatory testing of the pool constituents on the abbot prism found 1 donor to be (b)(6). The donation was not used for transfusion. Testing was completed in (b)(6) 2020. This issue was identified by the customer in (b)(6) 2021 after moving to a new qa system and the customer reported it to grifols at that time. The site did not have any sample to send to grifols for investigational testing. No additional information about the donor, such as (b)(6) infection or vaccine history, could be provided. Review of the device history record (dhr) for procleix ultrio elite ml 702238 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 hbv sensitivity issues from 12 months 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 702238 or the ultrio elite assay in general. The discordant results are consistent with results for a low titer sample where serology testing is (b)(6) but the viral load of the sample if not high enough to be consistently (b)(6) on the ultrio elite assay because the concentration does not meet the limit of detection of the assay. This could not be confirmed through quantitative testing of the sample as the customer did not have any available to return to grifols for investigation. Due to the lack of sample for investigational testing and the lack of additional information, the root cause of the results at the customer site could not be determined. No further information is expected, this is considered the final report.
 
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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 Key11499604
MDR Text Key252966974
Report Number2032600-2021-00001
Device Sequence Number1
Product Code QHO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
BL 125652
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/16/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Lot Number702238
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 Received02/17/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 03/16/2021 Patient Sequence Number: 1
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