MAUDE Adverse Event Report: ABBOTT IRELAND ARCHITECT ANTI-HBS

Catalog Number 07C18-29

Device Problem High Test Results (2457)

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

Event Date 07/05/2019

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.There was no additional patient information provided.This report is being filed on an international product, list number 7c18 that has a similar product distributed in the us, list number 1l82.

Event Description

The customer reported (b)(6) architect anti-hbs results on one patient.The results provided were: (b)(6) 2013 = (b)(6) / (b)(6) 2019 = (b)(6) / (b)(6) 2019 = (b)(6) / (b)(6) 2019 = (b)(6) / (b)(6) 2019 = (b)(6) / (b)(6) 2019 = (b)(6).There was no reported impact to patient management.

Manufacturer Narrative

A review of tickets found only one additional ticket for false reactive anti-hbs results for lot 01345fn00.A review of the trending report determined that there are no trends for the issue for the lot.Return testing was not completed as returns were not available.Historical performance in the field of architect anti-hbs reagent lots using world wide data through abbottlink was evaluated.The patient median result for lot 01345fn00 was comparable with all other lots in the field and confirms no systemic issue for the lot.A review of the manufacturing documentation did not identify any issues associated with the customer's observation.Labeling was reviewed which adequately addresses the current issue.The product labeling states that for diagnostic purposes, results should be used in conjunction with patient history and other hepatitis markers for diagnosis of acute, chronic, or recovered infection.It is possible that the potential falsely elevated results are due to reactivity following transfusion.Based on the investigation no product deficiency was identified for the architect anti-hbs reagent, lot 01345fn00.

• Brand Name: ARCHITECT ANTI-HBS
• Type of Device: ANTI-HBS
• Manufacturer (Section D): ABBOTT IRELAND; diagnostics division; finisklin business park; sligo NA ; EI NA
• MDR Report Key: 8838064
• MDR Text Key: 160374529
• Report Number: 3008344661-2019-00093
• 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: 10/14/2019

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: 05/14/2020
• Device Catalogue Number: 07C18-29
• Device Lot Number: 01345FN00
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/09/2019
• Initial Date FDA Received: 07/29/2019
• Supplement Dates Manufacturer Received: 10/07/2019
• Supplement Dates FDA Received: 10/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT I2000 ANALYZER, LN 08C89-01,; ARCHITECT I2000 ANALYZER, LN 08C89-01,; SERIAL # (B)(4); SERIAL # (B)(4)
• Patient Age: 82 YR