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 Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed a false positive architect b-hcg generated on an architect i2000sr analyzer for a female patient.Sid (b)(6) initial result = 104 iu/ml, repeat result = 1.2 iu/ml.There was no impact to patient management.
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 provided.
Additional Manufacturer Narrative
A complaint investigation was conducted for the architect total b-hcg reagent, lot 77139ud00.Review of tracking and trending by list number and by complaint lot did not identify any trends.Device history review did not identify any nonconformances, potential nonconformances or deviations associated with the customer¿s issue.The overall performance of architect total b-hcg reagents in the field was reviewed using data from customers worldwide.The patient median result for the complaint lot is within the established limits and comparable to other lots in the field, confirming no systemic issue for the complaint lot.Labeling was reviewed which adequately addresses the current issue.Based on the investigation, no systemic issue or deficiency was identified with the architect total b-hcg reagent, lot 77139ud00.
Event or Problem Description
The customer observed a false positive architect b-hcg generated on an architect i2000sr analyzer for a female patient.Sid (b)(6).Initial result = 104 iu/ml, repeat result = 1.2 iu/ml.There was no impact to patient management.

• 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: 23757313
• Report Number: 3005094123-2025-00633
• Device Sequence Number: 15981951
• Product Code: DHA
• UDI-Device Identifier: 00380740014964
• UDI-Public: (01)00380740014964(17)260605(10)77139UD00
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K983424
• 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): 02/03/2026

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: 06/05/2026
• Device Catalogue Number: 07K78-25
• Device Lot Number: 77139UD00
• 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: 11/20/2025
• Supplement Date Received by Manufacturer: 02/02/2026
• Initial Report FDA Received Date: 12/09/2025
• Supplement Report FDA Received Date: 02/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/15/2025
• 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 RECONDIT KO, 03M74-65, (B)(6).; ARC I2000SR RECONDIT KO, 03M74-65,(B)(6).
• Patient Sex: Female