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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 02/26/2021
Event Type  Injury  
Event Description
On (b)(6) 2021, grifols customer hospital (b)(6) reported discordant (b)(6) results for a sample that was originally (b)(6) when tested on (b)(6) 2021 with the procleix ultrio elite assay master lot 702238. On (b)(6) 2021, an archive sample from the same donor was tested with the procleix ultrio elite assay ml 703038 and was (b)(6). As a result of the initial (b)(6) result, there is a potential (b)(6) as a result of the infected blood product. The donor of the samples has been a regular donor since 2014. Prior to the events described, samples from this donor had always tested (b)(6). A donation from (b)(6) 2021 was (b)(6) when tested on the ultrio elite screening assay ml 703038. The donation was then tested using the ultrio elite discriminatory assays from the same ml 703038 resulting in the following: (b)(6). Grifols has requested additional information and is currently waiting for the results of the post-transfusion (b)(6) testing of the patient. The estimated date that the results will be available is unknown. Review of all provided run reports has been 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 records (dhr) for procleix ultrio elite mls 702238 and 703038 were performed. Dhr review confirmed that the master lots performed as expected and met all qc release specificity and sensitivity criteria. (b)(6) qc panels diluted to approximately 11 iu/ml and 4 iu/ml are used to release ultrio elite master lots. (b)(6). A review of grifols complaint records created for ultrio elite hbv 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 mls 702238 and 703038 or the ultrio elite assay in general. The procleix ultrio elite package insert (503049en rev. 005) shows hbv who (97/750) international standard 95% detection probability of 4. 3 iu/ml with 95% fiducial limits of 3. 8-5. 0 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. The (b)(6) donation gave (b)(6) results on the ultrio elite screening assay (ml 702238) when tested initially and the archive sample gave (b)(6) results on the ultrio elite assay (ml 703038). There is no indication based on the qc release data for mls 702238 and 703038 or the previous events search that the initial (b)(6) result of the (b)(6) donation is due to the master lot. The (b)(6) donation did not have enough sample for quantitative testing to be performed. The actual concentrations of the (b)(6) and (b)(6) donations could not be determined because they were below the limit of detection of the quantitative assay used, but the overall results of all testing for the (b)(6) donations could be due to samples with low (b)(6). Based on the information available and the (b)(6) result, the likely root cause of the discordant results of the (b)(6) sample between initial and archived sample testing is that the (b)(6) in the donation is below the limit of detection of the ultrio elite assay an update to this report will be filed when the post-transfusion (b)(6) testing results of the (b)(6) donation concentrated rbc recipient are received.
 
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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 Key12523773
MDR Text Key282330068
Report Number2032600-2021-00005
Device Sequence Number1
Product Code QHO
Combination Product (y/n)N
Reporter Country CodeSP
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 01/27/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/23/2021
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 Answer Provided
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/26/2021
Was Device Evaluated by Manufacturer? No Answer Provided

Patient Treatment Data
Date Received: 09/23/2021 Patient Sequence Number: 1
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