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 07C18-41

Device Problem High Test Results (2457)

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

Event Date 11/27/2023

Event Type  malfunction  

Event Description

The customer observed a falsely elevated architect anti-hbs result for one patient.The following data was provided: (b)(6) 2023 sid (b)(6) anti-hbs initial result = 20.62 miu/ml, elisa = nonreactive no impact to patient management was reported.

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.

Manufacturer Narrative

The complaint investigation for the architect anti-hbs assay 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 in house testing.Additionally, return sample analysis was completed.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.A search for similar complaints did not identify an increase in complaint activity for lot 51439fn00.A review of tracking and trending did not identify any related trends for the product for the issue.Device history record review on lot 51439fn00 did not identify any nonconformance's or deviations associated with lot number 51439fn00 and complaint issue.Labeling was reviewed and found to adequately address the issue under review.In-house specificity testing was completed with lot number 51439fn00.Testing met all acceptance criteria indicating the product is performing as expected and there is no issue with the lot.Return sample analysis: the returned specimen (sample id 824034) was tested with the architect anti-hbs reagent, lot 51439fn00.The reactive result obtained by the customer was replicated.Additional reference testing and testing with heterophilic blocking tubes (hbt) could not be performed as insufficient sample volume remained.However, test results (architect hiv ag/ab) for additional samples from the same patient tested with hbt indicates that the false reactive results were caused by interference due to heterophilic antibodies.Based on the investigation, no systemic issue or deficiency of the architect anti-hbs reagent for lot number 51439fn00 was identified.

Event Description

The customer observed a falsely elevated architect anti-hbs result for one patient.The following data was provided: (b)(6)2023 sid (b)(6)anti-hbs initial result = 20.62 miu/ml, elisa = nonreactive 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: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 18330224
• MDR Text Key: 330959394
• Report Number: 3008344661-2023-00198
• Device Sequence Number: 1
• Product Code: LOM
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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: 03/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07C18-41
• Device Lot Number: 51439FN00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/16/2023
• 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)