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 12/22/2023

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.All available patient information was included.Additional patient details are not available.This report is being filed on an international product, list number 07c18-29, that has a similar product distributed in the us, list number 01l82.

Event Description

The customer observed false reactive architect anti-hbs results for one patient.The customer suspects the results to be falsely reactive since it does not match results for the immunochromatography method.The following data was provided: architect results = 84.43 and 79.94 miu/ml.Immunochromatography method = negative.Other result = hbsag negative no impact to patient management was reported.

Event Description

The customer observed false reactive architect anti-hbs results for one patient.The customer suspects the results to be falsely reactive since it does not match results for the immunochromatography method.The following data was provided: architect results = 84.43 and 79.94 miu/ml immunochromatography method = negative other result = hbsag negative no impact to patient management was reported.

Manufacturer Narrative

The complaint investigation included a search for similar complaints, trending data review, labeling review, device history records review, field data, and scientific literature.Return testing was not completed as returns were not available.Review of all the information provided by the customer was reviewed.Ticket trending review did not identify any trends regarding commonalities for complaint lot.Device history review did not identify any non-conformances or deviations with the complaint lot.Historical performance in the field of reagent lots using worldwide data was evaluated.The patient median result for the lot is comparable with all other lots in the field and within established baselines, confirming no systemic issue for the product lot.Labeling was reviewed and sufficiently addresses the customer¿s issue.Additionally, a literature article, ¿interferences in immunoassay¿, tate and ward (2004), clin biochem rev, vol 25, 105, indicates analytical interference can lead to falsely elevated results and according to the literature, there is no single procedure that can rule out all interferences.It is important to recognize the potential for interference in immunoassay and to put procedures in place to identify them wherever possible.Most important is a consideration of the final clinical picture.If there is any clinical suspicion of discordance between the clinical and the laboratory data an attempt should be made to reconcile the difference.The detection of interference may require the use of an alternate assay, or measurement before and after treatment with additional blocking reagent or following dilution of the sample in non-immune serum.Based on the investigation, no systemic issue or deficiency of the architect anti-hbs reagent lot 49197fn00 was identified.All available patient information was included.Additional patient details are not available.

• 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: 18477733
• MDR Text Key: 332728358
• Report Number: 3008344661-2024-00006
• 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: 01/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07C18-29
• Device Lot Number: 49197FN00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/23/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC I1000SR MOD, 01L86-01, I1SR60811; ARC I1000SR MOD, 01L86-01, I1SR60811