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

Catalog Number	07K78-30
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed false positive architect total b-hcg results for one patient with mononucleosis syndrome, hepatic cytolysis, and asthenia.The following data was provided (>/=25.00 miu/ml is positive): sample id (b)(6) initial result, on (b)(6) 2025, was 33.10, repeat result was 33.04 miu/ml sample id (b)(6) result, on b)(6) 2025, was 33.90 miu/ml, repeat at biomnis, a different site, was 34 miu/ml sample id (b)(6) result, on (b)(6) , was 29.17 miu/ml, repeat at biomnis, different site using the radioimmuno assay, was <4.It was noted that the results at biomnis were for troubleshooting purposes.There was no impact to patient management reported.
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 entry = sample id (b)(6); sample id (b)(6).All available patient information was included.Additional patient details are not available.
Additional Manufacturer Narrative
Section d3 - email and section g1 - mfg site email updated.The complaint investigation for false positive architect total b-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.Return testing was not completed as returns were not available.A review of tracking and trending for the product and the likely cause lot did not identify an increase in complaint activity.Manufacturing documentation for the likely cause lot was reviewed and did not identify any issues.Device history record review on lot number 69543ud00 did not identify any non-conformances or deviations with the likely cause lot.The overall performance of architect total b-hcg reagents in the field was reviewed using data gathered from customers worldwide, with median patient results for the complaint lot within the established limits and comparable with other lots in the field, confirming no systemic issue for the lot.Based on the information provided and abbott diagnostics¿ complaint investigation, no systemic issue or deficiency of architect total b-hcg, lot number 69543ud00, was identified.
Event or Problem Description
The customer observed false positive architect total b-hcg results for one patient with mononucleosis syndrome, hepatic cytolysis, and asthenia.The following data was provided (>/=25.00 miu/ml is positive): sample id (b)(6) initial result, on (b)(6) 2025, was 33.10, repeat result was 33.04 miu/ml.Sample id (b)(6) result, on (b)(6) 2025, was 33.90 miu/ml, repeat at biomnis, a different site, was 34 miu/ml.Sample id (b)(6) result, on (b)(6) 2025, was 29.17 miu/ml, repeat at biomnis, different site using the radioimmuno assay, was <4.It was noted that the results at biomnis were for troubleshooting purposes.There was no impact to patient management 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: 22323364
• Report Number: 3005094123-2025-00319
• Device Sequence Number: 15658230
• Product Code: DHA
• UDI-Device Identifier: 00380740014971
• UDI-Public: (01)00380740014971(17)251128(10)69543UD00
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 08/29/2025

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: 11/28/2025
• Device Catalogue Number: 07K78-30
• Device Lot Number: 69543UD00
• 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: 06/04/2025
• Supplement Date Received by Manufacturer: 08/25/2025
• Initial Report FDA Received Date: 06/24/2025
• Supplement Report FDA Received Date: 08/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/18/2024
• 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 I2SR REFURB-SEKAT, 03M74-97, (B)(6).; ARC I2SR REFURB-SEKAT, 03M74-97, (B)(6).
• Patient Sex: Unknown