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

Catalog Number 303715

Device Problem Incorrect, Inadequate or Imprecise Result or 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.

• Brand Name: PROCLEIX ULTRIO ELITE ASSAY
• Type of Device: HIV-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 Key: 11845122
• MDR Text Key: 253612900
• Report Number: 2032600-2021-00002
• Device Sequence Number: 1
• Product Code: QHO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BL125652
• Number of Events Reported: 1
• 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 Received: 05/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 303715
• Device Lot Number: 703154
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other