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 07C18-29

Device Problem High Test Results (2457)

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

Event Date 09/15/2023

Event Type  malfunction  

Event Description

The customer reported falsely elevated architect anti-hbs and provided the following data for 1 patient: (reference = 10 miu/ml is regarded as being protective against hepatitis b viral infection per world health organization recommendation) patient information: 46 year old female with history of breast cancer surgery and also undergoing chemotherapy.The patient does not have a history of hepatitis b and has not received any blood transfusions or vaccinations since (b)(6) 2023.Anti-hbs results: (b)(6) 2023 (pre-surgery) result was 9.30 miu/ml (b)(6) 2023 (post-surgery) result was 31.45 miu/ml (b)(6) 2023 (post-surgery) result was 24.70 miu/ml the patient is scheduled for a retest and also reported that they plan to send sample to an outside reference laboratory.Other laboratory data: hbsag was negative, hbcab was negative.Reference lab results: a repeat test yielded positive results.When a dilution linearity test was performed, dilution linearity was poor.When an hbs antigen addition test was conducted, a significant decrease in the measured value was observed with the addition of the antigen, indicating that hbs antibodies were present in the sample.There was no reported impact to patient management.

Manufacturer Narrative

This report is being filed on an international product, list number 7c18 and there is a similar product distributed in the us, list number 1l82.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.

Event Description

The customer reported falsely elevated architect anti-hbs and provided the following data for 1 patient: (reference = 10 miu/ml is regarded as being protective against hepatitis b viral infection per world health organization recommendation) patient information: 46 year old female with history of breast cancer surgery and also undergoing chemotherapy.The patient does not have a history of hepatitis b and has not received any blood transfusions or vaccinations since (b)(6) 2023.Anti-hbs results: (b)(6) 2023 (pre-surgery) result was 9.30 miu/ml (b)(6) 2023 (post-surgery) result was 31.45 miu/ml (b)(6) 2023 (post-surgery) result was 24.70 miu/ml the patient is scheduled for a retest and also reported that they plan to send sample to an outside reference laboratory.Other laboratory data: hbsag was negative, hbcab was negative.Reference lab results: a repeat test yielded positive results.When a dilution linearity test was performed, dilution linearity was poor.When an hbs antigen addition test was conducted, a significant decrease in the measured value was observed with the addition of the antigen, indicating that hbs antibodies were present in the sample.There was no reported impact to patient management.

Manufacturer Narrative

The complaint investigation 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.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 did not identify an increase in complaint activity.Ticket trending review did not identify any trends.Device history review did not identify any non-conformances or deviations with the complaint lot.The overall performance of the architect anti-hbs reagents in the field was reviewed using data gathered from customers worldwide.The review of field data determined the patient median result for lot 47064fn00 is comparable with all other lots in the field and within established baselines, which does not indicate a systemic issue.Labeling was reviewed and sufficiently addresses the customer¿s issue.Based on the investigation, no systemic issue or deficiency was identified for the architect anti-hbs reagent, lot 47064fn00.

• 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: 17854263
• MDR Text Key: 324845848
• Report Number: 3008344661-2023-00172
• Device Sequence Number: 1
• Product Code: LOM
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 10/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/09/2024
• Device Catalogue Number: 07C18-29
• Device Lot Number: 47064FN00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/14/2023
• Initial Date FDA Received: 10/02/2023
• Supplement Dates Manufacturer Received: 10/04/2023
• Supplement Dates FDA Received: 10/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/20/2023
• 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).
• Patient Age: 46 YR
• Patient Sex: Female