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

Catalog Number 02G23-25

Device Problem False Positive Result (1227)

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

Event Date 09/02/2022

Event Type  malfunction  

Manufacturer Narrative

This report is being filed on an international product, list number 02g23 that has a similar product distributed in the us, list number 04p54.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer observed false positive architect hbsag qualitative ii confirmatory result for one patient.The customer had some imprecision issue with this assay and therefore decided to repeat the confirmatory testing.The repeated confirmatory result was negative.The following data was provided: sid (b)(6) hbsag initial result = 2.14 s/co (reactive), repeat results = 1.10 s/co (reactive), 1.04 s/co (reactive).Initial hbsag confirmatory result: hbsag %n = 76%, hbsag c2 result = 3.97 s/co (positive) repeat hbsag confirmatory result: hbsag %n =15%, hbsag c2 result = 1.33 s/co (negative) additional lab results provided: anti- hbc = nonreactive the customer believed the negative hbsag confirmatory is the correct result.No impact to patient management was reported.

Manufacturer Narrative

The complaint investigation false reactive architect hbsag quantitative ii confirmatory 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 completed as returns were not available.Data and information provided by the customer were reviewed and support the complaint issue.Ticket search by lot indicates that the reagent lot performs as expected for this product.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 number 34477fn00 and complaint issue.Labeling was reviewed and sufficiently addresses the customer's issue.In-house testing of a retained reagent kit of the complaint lot 34477fn00 was performed.All specifications were met which indicates the lot is performing acceptably.In this case, sample integrity issues or a preanalytical error with the initial testing could have contributed to the customer¿s observation.Per product labeling, if the architect hbsag qualitative ii confirmatory 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 and chronic infection.Based on this investigation, no systemic issue or deficiency with the architect hbsag quantitative ii confirmatory reagent, lot number 34477fn00 was identified.

• Brand Name: ARCHITECT HBSAG QUALITATIVE II CONFIRMATORY 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: 15481801
• MDR Text Key: 301004038
• Report Number: 3008344661-2022-00113
• Device Sequence Number: 1
• Product Code: LOM
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 11/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/08/2022
• Device Catalogue Number: 02G23-25
• Device Lot Number: 34477FN00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC I2K PROC MOD, 03M74-01, (B)(6) ; ARC I2K PROC MOD, 03M74-01, (B)(6)