MAUDE Adverse Event Report: ABBOTT IRELAND ARCHITECT ANTI-HBS REAGENT KIT; TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM)

Catalog Number 07C18-42

Device Problem False Positive Result (1227)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/18/2022

Event Type  malfunction  

Event Description

The customer observed false reactive architect anti-hbs result for one patient that did not match with the patient¿s historical result.The sample was repeated, and the results were nonreactive.The following data was provided: reference range: > / = 10.0 miu/ml is reactive.On (b)(6) 2022 sid (b)(6) initial result = 29.52 miu/ml, repeat results = 0.04 miu/ml, 0.12 miu/ml historical anti-hbs result: 0 miu/ml ((b)(6)2021) the customer released 0 miu/ml as a valid result.No impact to patient management was reported.

Manufacturer Narrative

Patient identifier: complete sid is (b)(6).All available patient information was included.Additional patient details are not available.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Manufacturer Narrative

This report is being filed on an international product, architect anti-hbs, list number 07c18, that has a similar product distributed in the us, architect ausab, list number 01l82.The complaint investigation for false reactive architect anti-hbs result included a review of data and information provided by the customer, search for similar complaints, ticket trending review, device history record review, and labeling review.In-house testing of retained reagent kit was also completed.Return testing was not performed as returns were not available.The customer observed a discoloration build up on the inner wall of the sample wash cup which could have contaminated the initial test.Data and information provided by the customer were reviewed and support the complaint issue.The ticket search determined normal complaint activity for the likely cause lot.A review of tracking and trending did not identify any related trends for the product for the complaint issue.Performance testing was completed using an in-house retained reagent kit of lot 35580fn00.All specifications were met indicating the lot is performing acceptably.The device history record was reviewed and did not identify any non-conformances or deviations associated with the complaint issue.Labeling was reviewed and sufficiently addresses the customer¿s issue.Per product labelling, if the anti-hbs results are inconsistent with clinical evidence, additional testing is suggested to confirm the result.For diagnostic purposes, results should be used in conjunction with patient history and other hepatitis markers for diagnosis of acute, chronic, or recovered infection.The overall specificity for the architect anti-hbs assay (determined by considering result values of = 10.00 miu/ml as reactive) was estimated to be 99.22% at the lower 95% confidence level, therefore false reactive results may at times occur.False positive results may arise as a result of sample or reagent integrity issues at time of testing and details regarding sample and reagent handling are provided within the product package insert.Based on the investigation, no systemic issue or product deficiency for architect anti-hbs reagent lot 35580fn00 was identified.

• Brand Name: ARCHITECT ANTI-HBS REAGENT KIT
• Type of Device: TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM)
• Manufacturer (Section D): ABBOTT IRELAND; finisklin business park; sligo F91VY 44; EI F91VY44
• Manufacturer (Section G): ABBOTT IRELAND; finisklin business park; sligo F91VY 44; EI F91VY44
• Manufacturer Contact: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 15390936
• MDR Text Key: 303559454
• Report Number: 3008344661-2022-00105
• Device Sequence Number: 1
• Product Code: LOM
• Combination Product (y/n): N
• Reporter Country Code: ID
• PMA/PMN Number: P050051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/13/2023
• Device Catalogue Number: 07C18-42
• Device Lot Number: 35580FN00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/28/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC I2000SR INST, 03M74-02, (B)(6); ARC I2000SR INST, 03M74-02, (B)(6); ARC I2000SR INST, 03M74-02, (B)(6)