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

Catalog Number 04P76-30

Device Problem False Positive Result (1227)

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

Event Date 06/19/2023

Event Type  malfunction  

Event Description

The customer observed false reactive architect hbsag next qualitative and architect hbsag next confirmatory results generated for a patient sample.The following data was provided (customer¿s reference range <1.0 s/co): (b)(6) 2023 sample id (b)(6) initial result = 1.07 s/co, repeat = 1.41 s/co.Architect hbsag next confirmatory test was performed and generated positive results: hbsagnx c2 = 1.43 s/co, hbsagnx%n = 97.17% neut, (b)(6) 2023 hbsag tested at another lab with a non-abbott instrument and result = 0.18 s/co, anti hbc result = 0.12 s/co (non-reactive), no impact to patient management was reported.

Manufacturer Narrative

An evaluation is in process.A final report will be submitted when the evaluation is complete.Section a1 - patient identifier complete entry = (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 04p76-35, that has a similar product distributed in the us, list number 04p76-37.

Event Description

The customer observed false reactive architect hbsag next qualitative and architect hbsag next confirmatory results generated for a patient sample.The following data was provided (customer¿s reference range <1.0 s/co): 19jun2023 sample id (b)(6) initial result = 1.07 s/co, repeat = 1.41 s/co.Architect hbsag next confirmatory test was performed and generated positive results: hbsagnx c2 = 1.43 s/co.Hbsagnx%n = 97.17% neut.18jul2023 hbsag tested at another lab with a non-abbott instrument and result = 0.18 s/co anti hbc result = 0.12 s/co (non-reactive).No impact to patient management was reported.Update: patient is a 28-year-old female.

Manufacturer Narrative

Update: additional information received on 07aug2023 after initial submission sent.Therefore information updated in the follwoing sections: a2 - age at time of event, a2 - age units (patient), a3 - gender, b5 - describe event or problem.An evaluation is in process.A final report will be submitted when the evaluation is complete.This report is being filed on an international product, list number 04p76-30, that has a similar product distributed in the us, list number 04p76-32.Corrected information provided on 08aug2023 after initial submissions sent.Therefore corrected information provided in the following sections below: d4 - catalog # corrected from 04p76-35 to 04p76-30.H10 - additional mfg narrative corrected from: this report is being filed on an international product, list number 04p76-35, that has a similar product distributed in the us, list number 04p76-37, to, this report is being filed on an international product, list number 04p76-30, that has a similar product distributed in the us, list number 04p76-32.

Manufacturer Narrative

The complaint investigation 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 testing of retained reagent kit.Return testing was not completed as returns were not available.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.Ticket search by lot indicates that the complaint lot performs as expected.A review of tracking and trending data did not identify any related trends.Device history record review did not identify any non-conformances, or deviations with the likely cause lot and complaint issue.Clinical specificity testing was performed using an in-house retained kit for lot 43304fn00, which is a sublot of 43255fn00.All specifications were met indicating the lot is performing acceptably.Labeling was reviewed and sufficiently addresses the customer's issue.Based on the investigation, no systemic issue or deficiency of the architect hbsag next qualitative reagent, lot number 43255fn00, was identified.

Event Description

The customer observed false reactive architect hbsag next qualitative and architect hbsag next confirmatory results generated for a patient sample.The following data was provided (customer¿s reference range <1.0 s/co): (b)(6) 2023 sample id (b)(6) initial result = 1.07 s/co, repeat = 1.41 s/co architect hbsag next confirmatory test was performed and generated positive results: hbsagnx c2 = 1.43 s/co hbsagnx%n = 97.17% neut (b)(6) 2023 hbsag tested at another lab with a non-abbott instrument and result = 0.18 s/co anti hbc result = 0.12 s/co (non-reactive) no impact to patient management was reported.Update: patient is a 28-year-old female.

• Brand Name: ARCHITECT HBSAG NEXT QUALITATIVE 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: 17467321
• MDR Text Key: 320577195
• Report Number: 3008344661-2023-00144
• Device Sequence Number: 1
• Product Code: LOM
• Combination Product (y/n): N
• Reporter Country Code: ID
• 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,Followup
• Report Date: 10/17/2023

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: 12/02/2023
• Device Catalogue Number: 04P76-30
• Device Lot Number: 43255FN00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/18/2023
• Initial Date FDA Received: 08/06/2023
• Supplement Dates Manufacturer Received: 08/07/2023; 10/17/2023
• Supplement Dates FDA Received: 08/09/2023; 10/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/28/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC HBSAG NEXT QUAL CON, 04P77-25, (B)(6).; ARC HBSAG NEXT QUAL CON, 04P77-25, (B)(6). ; ARC HBSAG NEXT QUAL CON, 04P77-25, (B)(6). ; ARC I2000SR INST, 03M74-02, (B)(6). ; ARC I2000SR INST, 03M74-02, (B)(6). ; ARC I2000SR INST, 03M74-02, (B)(6).
• Patient Age: 28 YR
• Patient Sex: Female