MAUDE Adverse Event Report: ABBOTT LABORATORIES PRISM HBCORE; ANTI-HBC

Catalog Number	06E66-68
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/10/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in-process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer reported a donor unit that was collected on (b)(6) 2016 generated a (b)(6) abbott prism hbcore result.The customer indicated the donor unit generated ultrio nat (b)(6).When separated out for individual testing, (b)(6).The customer further indicated the (b)(6) results were considered to be from the window phase of detection by prism and the blood unit was frozen for potential commercial resale.The donor unit was not transfused.
Additional Manufacturer Narrative
Ticket searches for the likely cause lot identified normal activity; no additional tickets for sensitivity were found.A review of the device history record for the likely cause lot did not reveal any issues related to the customer's observation.Review of the cber release panel testing for the likely cause lot was performed; all testing met specifications.Additionally, the tracking and trending review for the product determined that there were no adverse or nonstatistical trends identified.Further, a review of all tickets related to patient results for the assay since (b)(6) 2016 determined that this was the only ticket identified for sensitivity.Label reviews were also performed and found to adequately address the customer's issue.Since the likely cause reagent lot expired prior to the receipt of the complaint testing could not be performed.Therefore, a review of the prism field data was performed to assess performance of the abbott prism hbcore lot 63107m500.This review included a comparison of initial and repeat reactive rates for the lot to the package insert claims as well as a comparison to other masterlots within a similar timeframe.Additionally, positive and negative control data were compared to package insert specifications and other lots within a similar timeframe.The outcome of this review determined that the reagent lot to be within package insert claims and specifications as well as performing comparable to other lots within a similar timeframe.The fda-licensed hbv nat can detect evidence of infection at an earlier stage than is possible using approved antibody to hepatitis b core antigen (anti-hbc) tests.A review of all data associated with this complaint indicates these results are consistent with a "window donor" in which the onset of infection precedes the detectability of the abbott prism hbcore, however the evidence of infection is detectable by fda-licensed hbv nat testing.Based on the results of this investigation the prism hbcore assay is performing acceptably and no deficiency was identified.

• Brand Name: PRISM HBCORE
• Common Device Name: ANTI-HBC
• Manufacturer (Section D): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064 3500
• MDR Report Key: 6559252
• Report Number: 1415939-2017-00100
• Device Sequence Number: 10784025
• Product Code: LOM
• UDI-Device Identifier: 00380740062965
• UDI-Public: (01)00380740062965(17)170210(10)63107M500
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/10/2017
• Device Catalogue Number: 06E66-68
• Device Lot Number: 63107M500
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/10/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/10/2017
• Supplement Report FDA Received Date: 05/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ABBOTT PRISM SYSTEM, SIX CHANNEL; LIST 06A36-04 SERIAL (B)(4)
• Patient Age: 17 YR