MAUDE Adverse Event Report: ABBOTT IRELAND DIAGNOSTICS DIVISION ARCHITECT ANTI-HBS REAGENT KIT

Catalog Number 07C18-41

Device Problem High Test Results (2457)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/31/2020

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Patient identifier complete entry = (b)(6).All available patient information was included.Additional patient details are not available.This report is being filed on an international product, list number 07c18-41, that has a similar product distributed in the us, list number 01l82-27.

Event Description

The customer observed falsely elevated architect (b)(6) results for two patients.The following data was provided: sample id (b)(6), a (b)(6) year-old male, result on (b)(6) 2020, was (b)(6), a year ago testing was (b)(6).Sample id (b)(6), a (b)(6) year-old female, result on (b)(6) 2020, was (b)(6), six months ago testing was (b)(6).The samples were diluted to confirm dilution linearity and it seemed to be maintained.It was noted that the patients had been vaccinated a few years ago, however, these patients' results in the last five years have been (b)(6) and then suddenly increased.There was no impact to patient management reported.

Manufacturer Narrative

The complaint investigation for false reactive architect anti-hbs results included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, device history record review, and testing of retained reagent kits of the complaint lot number.Trending review determined no related trend for the issue for the product.Return testing was not completed, as returns were not available.Specificity testing was performed using an in-house retained kit of lot 10530fn00, stored at the recommended storage condition.All specifications were met indicating that the lot is performing acceptably.Device history record review did not identify any non-conformances or deviations with the likely cause lot and complaint issue.Manufacturing documentation for the likely cause lot was reviewed and did not identify any issues.Labeling was reviewed and sufficiently addresses the customer's issue.Based on the information provided and abbott diagnostics¿ complaint investigation, no systemic issue or deficiency of architect anti-hbs, lot number 10530fn00, was identified.

• Brand Name: ARCHITECT ANTI-HBS REAGENT KIT
• Type of Device: ARCHITECT ANTI-HBS
• Manufacturer (Section D): ABBOTT IRELAND DIAGNOSTICS DIVISION; finisklin business park; diagnostics division; sligo F91VY 44; EI F91VY44
• MDR Report Key: 10432690
• MDR Text Key: 232784755
• Report Number: 3008344661-2020-00064
• Device Sequence Number: 1
• Product Code: LOM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 10/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/17/2021
• Device Catalogue Number: 07C18-41
• Device Lot Number: 10530FN00
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/31/2020
• Initial Date FDA Received: 08/20/2020
• Supplement Dates Manufacturer Received: 10/20/2020
• Supplement Dates FDA Received: 10/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC I2K PROC MOD, 03M74-01, ((B)(6) ; ARCHITECT I2000 PROCESSING MODULE,; LIST# 03M74-01, SERIAL# (B)(6)