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 08/01/2023

Event Type  malfunction  

Event Description

The customer observed false reactive architect anti-hbs results for a 36-year-old patient with covid-19 infection.The patient does not have a history of hepatitis b and currently have no symptoms.The status of the patient¿s hepatitis b vaccination is unknown.The following data was provided: on (b)(6) 2024 architect anti-hbs result = 12.6 miu/ml.On (b)(6) 2023 architect anti-hbs result = 13.8 miu/ml.Other results provided: hbsag result = positive on (b)(6) 2024: hbv-dna = 7.4 iu/ml (positive); hbeag = 1180 s/co (positive); anti-hbe = 0.0 s/co (negative); anti-hbc = 6.47 s/co (positive) on (b)(6) 2023: hbv-dna = 7.7 iu/ml (positive); hbeag = 848 s/co (positive); anti-hbe = 0.0 s/co (negative); anti-hbc = 7.27 s/co (positive).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

Section e1 - facility name: (b)(6).This report is being filed on an international product, architect anti-hbs, list number 07c18-39, 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

Update: on (b)(6)2024, the customer provided the following reference lab results: reproducibility test = positive dilution linearity test = roughly satisfactory hbs antigen addition test = significant decrease in measured value was observed based on these results, anti-hbs were likely to be present in the sample.There was no impact to patient management reported.

Manufacturer Narrative

This follow up is being submitted to include the additional information provided by the customer on (b)(6)2024.The following sections were updated: section b5 - describe event or problem: this section was updated with additional information provided by the customer on (b)(6)2024.Section d4 - lot #: this section was updated from unknown to 51459fn00.Section d4 - primary udi number: this section was updated from (b)(6) 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 for a 36-year-old patient with covid-19 infection.The patient does not have a history of hepatitis b and currently have no symptoms.The status of the patient¿s hepatitis b vaccination is unknown.The following data was provided: (b)(6) 2024 architect anti-hbs result = 12.6 miu/ml (b)(6) 2023 architect anti-hbs result = 13.8 miu/ml other results provided: hbsag result = positive february 2024: hbv-dna = 7.4 iu/ml (positive); hbeag = 1180 s/co (positive); anti-hbe = 0.0 s/co (negative); anti-hbc = 6.47 s/co (positive) (b)(6) 2023: hbv-dna = 7.7 iu/ml (positive); hbeag = 848 s/co (positive); anti-hbe = 0.0 s/co (negative); anti-hbc = 7.27 s/co (positive) 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.Update: on (b)(6) 2024, the customer provided the following reference lab results: reproducibility test = positive dilution linearity test = roughly satisfactory hbs antigen addition test = significant decrease in measured value was observed based on these results, anti-hbs were likely to be present in the sample.There was no impact to patient management reported.

Manufacturer Narrative

Section d4 - catalog #: this section was corrected from 07c18-39 to 07c18-33.The complaint investigation for false reactive architect anti-hbs results included a review of data and information provided by the customer, a search for similar complaints, trending data review, device history record review, and labeling review.In addition, in-house testing of retained reagent kit was also completed.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 51459fn00 and the complaint issue.A review of labeling was performed and found to sufficiently address the customer's issue.A clinical specificity testing was performed using an in-house retain kit of lot 51459fn00.All specifications were met which indicates the product is performing as expected.Based on the investigation, no systemic issue or deficiency was identified.The architect anti-hbs reagent, lot number 51459fn00 is performing as expected.

• 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: 18927420
• MDR Text Key: 337958704
• Report Number: 3008344661-2024-00038
• 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
• Report Date: 03/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07C18-39
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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, ISR60045; ARC I2K PROC MOD, 03M74-01, ISR60045; ARC I2K PROC MOD, 03M74-01, ISR60045
• Patient Age: 36 YR