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U.S. Department of Health and Human Services

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

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GRFIOLS DIAGNOSTIC SOLUTIONS INC. PROCLEIX ULTRIO ELITE ASSAY HIV-1/HIV-2/HCV/HBV DEVICE Back to Search Results
Catalog Number 303715
Device Problem Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problem Insufficient Information (4580)
Event Date 03/26/2021
Event Type  Injury  
Event Description
On (b)(6) 2021, grifols customer qualtex labs ((b)(6) reported a procleix ultrio elite assay nonreactive, hiv serology positive result in a serum sample. Plasma from the same donor was retested in duplicate with the procleix ultrio elite assay and was reactive in both replicates. The plasma sample was also tested with the procleix hiv discriminatory assay (dhiv) and was hiv reactive. The customer released results as ultrio elite reactive, dhiv reactive and the sample was discarded. No volume remains for investigation and no donor history was available. A previous events search showed one other complaint (b)(4) for ultrio elite false negative over the prior year. The root cause was determined to be low titer sample. The reagent qc release data was reviewed and there were no indications of a problem with hiv sensitivity. Master lot 703154 passed all sensitivity specifications for hiv-1 and hiv-2, in addition to all other analytes and specifications. Without remaining sample volume for investigation, root cause could not be determined. Based on the previous events search and the review of the master lot release data, the most likely root cause is low titer hiv. 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)
GRFIOLS DIAGNOSTIC SOLUTIONS INC.
4560 horton street
emeryville CA 94608
Manufacturer Contact
amanda doe
10808 willow court
san diego, CA 92127
8582020852
MDR Report Key11845122
MDR Text Key253612900
Report Number2032600-2021-00002
Device Sequence Number1
Product Code QHO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
BL125652
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 05/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/18/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number303715
Device Lot Number703154
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 Received04/19/2021
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: 05/18/2021 Patient Sequence Number: 1
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