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 12/20/2023

Event Type  malfunction  

Manufacturer Narrative

This report is being filed on an international product, architect anti-hbs, list number 07c18-29, that has a similar product distributed in the us, list number 01l82.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer observed falsely elevated architect anti-hbs result for one patient when compared to the previous result.The following data was provided: result = over 10 miu/ml.Previous result = 9 miu/ml.Per the architect anti-hbs package insert, interpretation of results section which states an anti-hbs concentration = 10 miu/ml is regarded as being protective against hepatitis b viral infection.There was no impact to patient management reported.

Manufacturer Narrative

The complaint investigation included a review of data and information provided by the customer, a search for similar complaints, trending data review, labeling review, device history record review, field data review, and literature review.Return testing was not completed as returns were not available.The data and information provided by the customer were reviewed and support the complaint issue.A ticket search by lot indicates that the reagent lot performs as expected for this product.A review of the complaint trending report did not identify any trends for the issue for the product.A review of the device history record did not identify any non-conformances or deviations with lot 52507fn00 and the complaint issue.The overall performance of the architect anti-hbs assay was reviewed using field data from customers worldwide.The patient median result for lot 52507fn00 is comparable with other lots in the field and within established baselines which confirms no systemic issue for the lot.A review of labeling was performed and found to sufficiently address 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 52507fn00 was identified.

Event Description

The customer observed falsely elevated architect anti-hbs result for one patient when compared to the previous result.The following data was provided: result = over 10 miu/ml.Previous result = 9 miu/ml.Per the architect anti-hbs package insert, interpretation of results section which states an anti-hbs concentration = 10 miu/ml is regarded as being protective against hepatitis b viral infection.There was no impact to patient management 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: 18480721
• MDR Text Key: 332539073
• Report Number: 3008344661-2024-00007
• 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: 01/28/2024

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: 52507FN00
• 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: 07/04/2023
• 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, ISR60721; ARC I2K PROC MOD, 03M74-01, ISR60721