MAUDE Adverse Event Report: ABBOTT IRELAND DIAGNOSTICS DIVISION ARCHITECT TOTAL B-HCG; SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN

Catalog Number	07K78-25
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2025
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.All available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer observed a false negative architect total b-hcg result for one patient.The patient was positive by another method.The following data was provided: architect initial result = <1.20 miu/ml retested with another reagent same lot = <1.20 miu/ml immunochromatography method was positive with a urine sample.No impact to patient management was reported.
Additional Manufacturer Narrative
The complaint investigation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, device history record review, in house testing and labeling review.Data and information provided by the customer were reviewed and support the complaint issue.A search for similar complaints identified an increase in complaint activity for lot 67166ud00.However, review of tracking and trending for the architect total b-hcg assay did not identify an increase in complaint activity regarding commonalities for lot numbers and issue.A device history record review did not identify any related nonconformances, potential nonconformances or deviations associated with the complaint lot number and complaint issue.In house accuracy testing was completed using panels which mimic patient samples using a retained kit stored at the recommended storage condition.All specifications were met indicating that the lot is performing acceptably.Labelling was reviewed which adequately addresses the current issue.Based on the investigation, no systemic issue or deficiency of the architect total b-hcg reagent lot 67166ud00 was identified.
Event or Problem Description
The customer observed a false negative architect total b-hcg result for one patient.The patient was positive by another method.The following data was provided: architect initial result = <1.20 miu/ml retested with another reagent same lot = <1.20 miu/ml immunochromatography method was positive with a urine sample.No impact to patient management was reported.

• Brand Name: ARCHITECT TOTAL B-HCG
• Common Device Name: SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN
• Manufacturer (Section D): ABBOTT IRELAND DIAGNOSTICS DIVISION; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• Manufacturer (Section G): ABBOTT IRELAND DIAGNOSTICS DIVISION; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• Manufacturer Contact: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 22520859
• Report Number: 3005094123-2025-00360
• Device Sequence Number: 8078923
• Product Code: DHA
• UDI-Device Identifier: 00380740014964
• UDI-Public: (01)00380740014964(17)250920(10)67166UD00
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2025

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: 09/20/2025
• Device Catalogue Number: 07K78-25
• Device Lot Number: 67166UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2025
• Supplement Date Received by Manufacturer: 09/10/2025
• Initial Report FDA Received Date: 07/16/2025
• Supplement Report FDA Received Date: 09/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/09/2024
• 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 I1000SR MOD, 01L86-01, (B)(6).; ARC I1000SR MOD, 01L86-01, (B)(6).
• Patient Sex: Unknown