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

Catalog Number 02G22-25

Device Problem False Positive Result (1227)

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

Event Date 02/17/2023

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer observed false repeat reactive architect hbsag qualitative ii results for one patient sample.The sample was sent out and the result came back as nonreactive.The following data was provided: on (b)(6) 2023, (b)(6) initial result = 4.28 repeat 85.09.Sent out to another lab(method unknown) = nonreactive.Neutralizing confirmatory testing was done in another lab per customer.There was no reported impact to patient management.

Event Description

The customer observed false repeat reactive architect hbsag qualitative ii results for one patient sample.The sample was sent out and the result came back as nonreactive.The following data was provided: 17feb2023 sid (b)(6) initial result = 4.28 repeat 85.09.Sent out to another lab(method unknown) = nonreactive.Additional data provided 23mar2023 results from other lab provided testing performed on the alinity results = abbott alinity hbsag 0.55 s/co (negative).Abbott alinity hbcab 0.10 (negative).Customer now confirms that no confirmatory testing was done on sample as the screen at the other lab was initially non reactive.There was no reported impact to patient management.

Manufacturer Narrative

A complaint investigation was conducted and after review of the available information there was no deficiency of the device identified.There was no risk for death or serious deterioration in state of health identified for the event, therefore this event is no longer reportable.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.The ticket search by lot indicates that the likely cause lot performs as expected for this product.Return testing was not performed as returns were not available.Device history record review was performed on lot 44540fn00, which did not show any potential non-conformances, deviations, or non-conformances.Trending review did not identify any trends for the complaint issue.Customer field data was used to assess the performance of the architect hbsag qualitative ii assay using worldwide data through abbottlink.Review of the data for the negative population shows that the median patient result for reagent lot 44540fn00 falls within 3sd of the mean indicating the reagent lot is performing acceptably on market.Labeling review concludes that the issue is adequately addressed.The hbsag assay is a screening parameter where it is known that initial reactives happen.Instructions are provided in the product package insert with regard to initial reactive results.2g22 is a highly sensitive assay which might be susceptible to interfering substances that might trigger positive assay readings.Neutralization will reveal if the signal was generated by hbsag or interfering substances.In this case, the customer did not perform testing with a neutralizing confirmatory assay so the final interpretation cannot be determined.A malfunction was not identified.Based on the information within the complaint record, the device met performance specifications and performed as intended at the customer site.A systemic issue and/or product deficiency was not identified.

• Brand Name: ARCHITECT HBSAG QUALITATIVE II 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: 16536535
• MDR Text Key: 311212147
• Report Number: 3008344661-2023-00052
• Device Sequence Number: 1
• Product Code: LOM
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: P110029
• 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: 05/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/29/2023
• Device Catalogue Number: 02G22-25
• Device Lot Number: 44540FN00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/05/2022
• 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, ISR50473; ARC I2000SR INST, 03M74-02, ISR50473