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

Catalog Number 07C18-74

Device Problem High Test Results (2457)

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

Event Date 07/20/2023

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.This report is being filed on an international product, list number 7c18 has a similar product distributed in the us, list number 1l82.

Event Description

The customer observed falsely elevated architect anti-hbs result for one sample.The following data was provided (customer provided reference range: 0 to 10 miu/ml initial result = 395.95 miu/ml, repeat with another method (domestic chemclin luminescence platform) was negative.No impact to patient management was reported.

Manufacturer Narrative

The complaint investigation for falsely elevated 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 field data review.Return testing was not completed as returns were not available.Trending review did not identify any trends for the issue for the product.Device history record review did not identify any non-conformances or deviations with lot 45102fn01 and the complaint issue.The overall performance of architect anti-hbs was reviewed using field data from customers worldwide.The patient median result for the lot is comparable with all other lots in the field and within established baselines, confirming no systemic issue for the product lot.Labeling was reviewed and found to be adequate.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/protective results may at times occur.False elevated 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.Review of the publication, tate and ward (2004), ¿interferences in immunoassay¿, clin biochem rev, vol 25, 105.Analytical interference can lead to falsely elevated results and according to the literature, there is no single procedure that can rule out all interferences.It is important to recognize the potential for interference in immunoassay and to put procedures in place to identify them wherever possible.Most important is a consideration of the final clinical picture.If there is any clinical suspicion of discordance between the clinical and the laboratory data an attempt should be made to reconcile the difference.The detection of interference may require the use of an alternate assay, or measurement before and after treatment with additional blocking reagent or following dilution of the sample in non-immune serum.Based on our investigation, no systemic issue or deficiency with the architect anti-hbs reagent for lot 45102fn01 was identified.

Event Description

The customer observed falsely elevated architect anti-hbs result for one sample.The following data was provided (customer provided reference range: 0 to 10 miu/ml initial result = 395.95 miu/ml, repeat with another method (domestic chemclin luminescence platform) was negative.No impact to patient management was reported.

• 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 DIAGNOSTICS DIVISION; finisklin business park; sligo F91VY 44; EI F91VY44
• Manufacturer (Section G): ABBOTT IRELAND DIAGNOSTICS DIVISION; 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: 17413582
• MDR Text Key: 319987671
• Report Number: 3008344661-2023-00134
• Device Sequence Number: 1
• Product Code: LOM
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 09/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/24/2023
• Device Catalogue Number: 07C18-74
• Device Lot Number: 45102FN01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2022
• 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, ISR54662