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

Catalog Number	01L82-27
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Section a1 patient identifier complete information: (b)(6).All available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer observed a false positive architect ausab result generated on the architect i2000sr processing module for one sample.The following results were provided: sid (b)(6) initial ausab result = 19.64 miu/ml, repeat result = 0.48 miu/ml, repeat result on ((b)(6)) 0.12 miu/ml no impact to patient management was reported.
Event or Problem Description
The customer observed a false positive architect ausab result generated on the architect i2000sr processing module for one sample.The following results were provided: sid (b)(6) initial ausab result = 19.64 miu/ml, repeat result = 0.48 miu/ml, repeat result on ((b)(6)) 0.12 miu/ml no impact to patient management was reported.
Additional Manufacturer Narrative
The complaint investigation for falsely reactive architect ausab results included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, and device history record 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 without indication for any additional issue.The ticket search by lot indicates that the reagent lot performed as expected for this product.A review of tracking and trending did not identify any trends for the complaint issue.The device history record review did not show any nonconformances or deviations associated with the likely cause lot number and complaint issue.Based on the investigation, no systemic issue or deficiency of the architect ausab for lot number 55204fn00 was identified.All available patient information was included.Additional patient details are not available.

• Brand Name: ARCHITECT AUSAB REAGENT KIT
• Common Device Name: 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: 19309515
• Report Number: 3008344661-2024-00056
• Device Sequence Number: 17895003
• Product Code: LOM
• UDI-Device Identifier: 00380740115364
• UDI-Public: (01)00380740115364(17)241112(10)55204FN00
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P050051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/12/2024
• Device Catalogue Number: 01L82-27
• Device Lot Number: 55204FN00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/25/2024
• Supplement Date Received by Manufacturer: 07/19/2024
• Initial Report FDA Received Date: 05/14/2024
• Supplement Report FDA Received Date: 07/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/15/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARC I2000SR REFURB-MEXI, 03M74-84, (B)(6).; ARC I2000SR REFURB-MEXI, 03M74-84, (B)(6).
• Patient Sex: Unknown