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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GRIFOLS DIAGNOSTIC SOLUTIONS INC. PROCLEIX ULTRIO PLUS ASSAY HIV-1/HCV/HBV DEVICE

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GRIFOLS DIAGNOSTIC SOLUTIONS INC. PROCLEIX ULTRIO PLUS ASSAY HIV-1/HCV/HBV DEVICE Back to Search Results
Lot Number 702056
Device Problem Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problem Test Result (2695)
Event Date 07/06/2020
Event Type  Injury  
Event Description
On 08oct2020, grifols customer, (b)(6) in (b)(6), reported a discrepant (b)(6) result between serology and the procleix ultrio plus assay. The customer had a donation that was (b)(6), anti-(b)(6), and anti-(b)(6) but the pool of 16 that it was tested in was nonreactive when tested with procleix ultrio plus ml 702056. Testing took place in (b)(6) 2020. At the time of reporting to grifols, (b)(6) had not analyzed this donation individually on ultrio plus, or other nat methods. The customer confirmed that the donation was rejected for use as it is standard practice for them to reject donations that are serology (b)(6). The other 15 samples in the pool were serology (b)(6) and were released. (b)(6) will perform additional testing for the individual donation using procleix ultrio plus, and procleix ultrio elite assays during the week of (b)(6) 2020, and provide that information to grifols when available. The site will also be sending back sample to grifols for additional testing. Grifols will send the samples to a reference lab for (b)(6) quantitative testing. Grifols qa performed a previous events search of similar complaints and reviewed the qc release data for procleix ultrio plus ml702056. Review of the qc release data, and a previous events search in the grifols complaint system indicate that the assay is working as designed. Follow-up information for this report will be provided as necessary.
 
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Brand NamePROCLEIX ULTRIO PLUS ASSAY
Type of DeviceHIV-1/HCV/HBV DEVICE
Manufacturer (Section D)
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
4560 horton street
emeryville CA 94608
Manufacturer Contact
richa padhya
10808 willow court
san diego, ca 
2020826
MDR Report Key10788944
MDR Text Key216831697
Report Number2032600-2020-00005
Device Sequence Number1
Product Code QHO
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
BL 125113
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,Followup
Report Date 02/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/04/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Lot Number702056
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 Received10/08/2020
Was Device Evaluated by Manufacturer? No
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: 11/04/2020 Patient Sequence Number: 1
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