MAUDE Adverse Event Report: ABBOTT IRELAND DIAGNOSTICS DIVISION ARCHITECT HBSAG REAGENT KIT; TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM)

Catalog Number 06C36-78

Device Problem Low Test Results (2458)

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

Event Date 08/24/2023

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A final report will be submitted when the evaluation is complete.Section e1 - address 1, phone number, facility name: (b)(6).All available patient information was included.Additional patient details are not available.  this report is being filed on an international product, list number 6c36, that has a similar product distributed in the us, list number 4p53.

Event Description

The customer observed a false non-reactive architect hbsag result generated for a patient sample with a history of hepatitis b.The following data was provided (customer¿s reference range 0-0.05 iu/ml is negative): initial result = 0.00 iu/ml, repeat = 0.00 iu/ml; previous results: (b)(6) 2020 result = 219.11 iu/ml; 2021 result = positive.No impact to patient management was reported.

Event Description

The customer observed a false non-reactive architect hbsag result generated for a patient sample with a history of hepatitis b.The following data was provided (customer¿s reference range 0-0.05 iu/ml is negative): initial result = 0.00 iu/ml, repeat = 0.00 iu/ml previous results: on (b)(6) 2020 result = 219.11 iu/ml; 2021 result = positive no impact to patient management was reported.

Manufacturer Narrative

Update: section d4 - expiration date updated from 2/24/2024 to 2/14/2024 the complaint investigation for false nonreactive architect hbsag results 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 in-house sensitivity testing.Return testing was not completed as returns were not available.Data and information provided by the customer was reviewed and support the complaint issue without indication for any additional issue.The ticket search by lot number indicates the reagent lot is performing as expected.The ticket trending review for the likely cause list number did not identify any trends for the likely cause lot and complaint issue.A review of the labeling adequately addresses the customer¿s issue.Device history review did not identify any nonconformances, potential nonconformances, or deviations associated with the likely cause lot number and the complaint issue.In-house sensitivity testing using a retained reagent kit of lot 48520fn00 was performed.All specifications were met indicating that the lot is performing acceptably.Based on the investigation, no systemic issue or deficiency with the architect hbsag lot 48520fn00 was identified.

• Brand Name: ARCHITECT HBSAG 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: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 17666670
• MDR Text Key: 322522927
• Report Number: 3008344661-2023-00167
• Device Sequence Number: 1
• Product Code: LOM
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: N/A
• 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: 09/15/2023

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: 02/14/2024
• Device Catalogue Number: 06C36-78
• Device Lot Number: 48520FN00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/24/2023
• Initial Date FDA Received: 08/31/2023
• Supplement Dates Manufacturer Received: 09/14/2023
• Supplement Dates FDA Received: 09/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC I2000SR INST, 03M74-02, (B)(6); ARC I2000SR INST, 03M74-02, (B)(6)