MAUDE Adverse Event Report: ABBOTT GMBH ARCHITECT ANTI-HBC II REAGENT KIT; TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM)

Catalog Number 08L44-25

Device Problem False Negative Result (1225)

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

Event Date 05/20/2022

Event Type  malfunction  

Manufacturer Narrative

This report is being filed on an international product, architect anti-hbc ii, list number, that has a similar product distributed in the us, list number 06l22.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer observed false nonreactive architect anti-hbc ii result for one patient whose previous result was reactive.The patient was also recently tested, and the result was reactive.The following data was provided: on (b)(6) 2022 result = nonreactive, on (b)(6) 2023 result = reactive, previous result from (b)(6) 2020 = reactive, no impact to patient management was reported.

Manufacturer Narrative

The complaint investigation for false nonreactive architect anti-hbc ii results included a review of data and information provided by the customer, search for similar complaints, ticket trending review, device history record review, and labeling review.Return testing was not completed as returns were not available.Data and information provided by the customer were reviewed and support the complaint issue.Ticket search by lot indicated the reagent lot is performing as expected for this product.Trending review did not identify any trends for the issue for the product.Device history record review did not identify any non-conformances, or deviations with lot 35469be00 and complaint issue.Labeling was reviewed and sufficiently addresses the complaint issue.In-house testing could not be performed since the complaint lot has already been expired when the complaint ticket was received.Based on this investigation, no systemic issue or deficiency was identified for the architect anti-hbc ii reagent lot 35469be00.The following sections were corrected: d4 - expiration date was corrected from 07apr2022 to 15dec2022.H4 - device mfg date was corrected from 21may2021 to 02feb2022.

• Brand Name: ARCHITECT ANTI-HBC II REAGENT KIT
• Type of Device: TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM)
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer (Section G): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer Contact: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 16350748
• MDR Text Key: 309315189
• Report Number: 3002809144-2023-00081
• Device Sequence Number: 1
• Product Code: LOM
• Combination Product (y/n): N
• Reporter Country Code: IS
• 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: 03/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/15/2022
• Device Catalogue Number: 08L44-25
• Device Lot Number: 35469BE00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/02/2022
• 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, I1SR54168; ARC I1000SR MOD, 01L86-01, I1SR54168