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

Catalog Number 04P54-25

Device Problems False Positive Result (1227); High Test Results (2457)

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

Event Date 09/25/2023

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.All available patient information was included.Additional patient details are not available.

Event Description

The customer observed falsely reactive architect hbsag results generated on the architect i2000sr processing module for multiple patient samples.Additionally, the customer reported an increase in reactive rates from 2% to 19% for (b)(6) 2023 and (b)(6)2023.(b)(6) 2023 initial reactive samples were recentrifuged and repeat reactive in duplicate with confirmed positive results that had similar s/co values and % neutralization (no specific data was provided).(b)(6) 2023 an obstetric gynecology (obgyn) physician questioned a confirmed positive result for a mother of a newborn.The patients that were redrawn were negative for hbsag and the viral load testing was performed on 2 of the patients (on the redrawn sample) were negative.The samples that were repeat reactive and confirmed reactive were from outpatient laboratory sites.No impact to patient management was reported.

Event Description

The customer observed falsely reactive architect hbsag results generated on the architect i2000sr processing module for multiple patient samples.Additionally, the customer reported an increase in reactive rates from 2% to 19% for (b)(6)2023 and (b)(6)2023.(b)(6)2023 initial reactive samples were recentrifuged and repeat reactive in duplicate with confirmed positive results that had similar s/co values and % neutralization (no specific data was provided).(b)(6)2023 an obstetric gynecology (obgyn) physician questioned a confirmed positive result for a mother of a newborn.The patients that were redrawn were negative for hbsag and the viral load testing was performed on 2 of the patients (on the redrawn sample) were negative.The samples that were repeat reactive and confirmed reactive were from outpatient laboratory sites.No impact to patient management was reported.

Manufacturer Narrative

The complaint investigation for false reactive architect hbsag qualitative confirmatory 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 testing.Return testing was not completed as returns were not available.Review of all the information provided by the customer was reviewed.A review of tracking and trending did not identify any related trends for the product for the issue.Device history record review on lot 54583fn00 did not show any potential non-conformances, deviations, or non-conformances associated with the complaint issue.Labeling was reviewed and sufficiently addresses the customer's issue.In-house specificity testing was performed using an in-house retained kit of lot 54583fn00.All specifications were met indicating that the lot is performing acceptably.Based on the investigation, no systemic issue or deficiency with the architect hbsag qualitative confirmatory assay for lot 54583fn00 was identified.All available patient information was included.Additional patient details are not available.Corrected information in section h6 - medical device problem code.

• Brand Name: ARCHITECT HBSAG QUALITATIVE CONFIRMATORY 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: 17952486
• MDR Text Key: 325916950
• Report Number: 3008344661-2023-00181
• Device Sequence Number: 1
• Product Code: LOM
• UDI-Device Identifier: 00380740007799
• UDI-Public: 00380740007799
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/17/2023

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: 02/29/2024
• Device Catalogue Number: 04P54-25
• Device Lot Number: 54583FN00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/03/2023
• Initial Date FDA Received: 10/17/2023
• Supplement Dates Manufacturer Received: 11/15/2023
• Supplement Dates FDA Received: 11/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2023
• 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), (B)(6); ARC I2000SR INST, 03M74-02, (B)(6), (B)(6)
• Patient Sex: Female