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 07C18-39

Device Problem High Test Results (2457)

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

Event Date 02/12/2024

Event Type  malfunction  

Manufacturer Narrative

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 observed false reactive architect anti-hbs results on one 23-month-old baby.The results provided were: on (b)(6) 2024 anti-hbs=> 1000 miu/ml (>or =10 miu/ml consider being protective against hepatitis b viral infection) additional information: hbsag=negative (no actual results provided) results on baby¿s mother= in 2020 anti-hbs=negative; on (b)(6) 2021 anti-hbs=positive there was no reported impact to patient management.

Manufacturer Narrative

The complaint evaluation 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 for architect anti-hbs reagent, lot 51252fn00.The ticket search determined that there is as expected complaint activity for the likely cause lot.A review of tracking and trending data did not identify any related trends for the product for the issue.Return testing was not completed as returns were not available.Device history record review did not identify any non-conformances or deviations with the complaint lot and complaint issue.Historical performance of the architect anti-hbs reagents in the field was reviewed using data gathered via abbottlink from customers worldwide.The median value of the patient population for the complaint lot 51252fn00 is within the established limits and comparable to historical reagent lot performance.All field data demonstrating that the lot is performing as expected.A review of the labeling addresses the customer¿s issue.Per product labelling, if the anti-hbs 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, chronic, or recovered infection.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 results may at times occur.False positive 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.A manufacturing documentation for the likely cause lot did not identify any issues associated with the complaint issue.Based on the investigation no product deficiency was identified for the architect anti-hbs reagent, lot 51252fn00.

Event Description

The customer observed false reactive architect anti-hbs results on one 23-month-old baby.The results provided were: on (b)(6) 2024 anti-hbs=> 1000 miu/ml (>or =10 miu/ml consider being protective against hepatitis b viral infection).Additional information: hbsag=negative (no actual results provided) results on baby¿s mother= in 2020 anti-hbs=negative; on (b)(6) 2021 anti-hbs=positive there was no reported impact to patient management.

• 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: 18840420
• MDR Text Key: 336990718
• Report Number: 3008344661-2024-00031
• 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: 03/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07C18-39
• Device Lot Number: 51252FN00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/25/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: ARC I2K PROC MOD, 03M74-01, (B)(6) ; ARC I2K PROC MOD, 03M74-01, (B)(6)
• Patient Age: 23 MO