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	12/28/2025
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.Complete information from section a1 patient identifier: sid (b)(6).All available patient information has been included.No additional patient details are available.
Event or Problem Description
The customer observed false positive architect total b-hcg results for a 30-year-old female patient.The following data was provided: sid (b)(6), (b)(6) 2025) 128.58 miu/ml, repeated (b)(6) 2025) <1.20 miu/ml.No impact to patient management was reported.
Additional Manufacturer Narrative
The complaint investigation for false positive architect total -hcg 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 field data review for the complaint lot.The ticket search by lot indicates that the reagent lot performs as expected for this product.Ticket trending review for the list number did not identify any related trends.Device history record review did not identify any non-conformances or deviations associated with lot 78462ud00 and the complaint issue.The overall performance of architect total -hcg reagents in the field was reviewed using data gathered from customers worldwide.The number of standard deviations to cut-off for the negative population and the patient median values obtained with the complaint lot 78462ud00 are within established limits and comparable to the historical lot performance.Labeling was reviewed and was found to address the customer reported issue.Based on our investigation, no systemic issue or deficiency with the architect total -hcg reagent, lot 78462ud00 was identified.
Event or Problem Description
The customer observed false positive architect total b-hcg results for a 30-year-old female patient.The following data was provided: sid (b)(6) ((b)(6) 2025) 128.58 miu/ml, repeated ((b)(6) 2025) <1.20 miu/ml.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: 24056768
• Report Number: 3005094123-2026-00018
• Device Sequence Number: 15958407
• Product Code: DHA
• UDI-Device Identifier: 00380740014964
• UDI-Public: (01)00380740014964(17)260725(10)78462UD00
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• 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): 03/13/2026

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: 07/25/2026
• Device Catalogue Number: 07K78-25
• Device Lot Number: 78462UD00
• 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: 12/30/2025
• Supplement Date Received by Manufacturer: 03/09/2026
• Initial Report FDA Received Date: 01/13/2026
• Supplement Report FDA Received Date: 03/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/14/2025
• 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 I1000SR INTGR, 01L86-40, (B)(6).; ARC I1000SR INTGR, 01L86-40, (B)(6).
• Patient Age: 30 YR
• Patient Sex: Female