MAUDE Adverse Event Report: ABBOTT IRELAND DIAGNOSTICS DIVISION ARCHITECT TOTAL B-HCG REAGENT KIT; 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	04/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed a falsely elevated architect total hcg result generated on the architect i1000sr processing module for two patients.The following results were provided: (b)(6), sid (b)(6) initial result = 600.37 iu/l, new sample result = <1.2 iu/l (b)(6) 2025 repeat result from previous sample = >1.2 iu/l the following results were provided and the four sids are for the same patient: (b)(6) 2025 sid (b)(6) initial result 31.28 iu/l, repeat results with (b)(6) = <1.20 iu/l, sid kerr967rpt = <1.20 iu/l, sid kerr1108rpt = <1.20 iu/l no impact to patient management was reported.
Additional Manufacturer Narrative
Section a1 patient identifier complete information: (b)(6).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 falsely elevated architect total -hcg result generated on the architect i1000sr processing module for two patients.The following results were provided: on (b)(6) 2025, sid (b)(6), initial result = 600.37 iu/l, new sample result = <1.2 iu/l.On (b)(6) 2025 repeat result from previous sample = >1.2 iu/l.The following results were provided and the four sids are for the same patient: on (b)(6) 2025, sid (b)(6), initial result 31.28 iu/l, repeat results with sid (b)(6) = <1.20 iu/l, sid (b)(6) = <1.20 iu/l, sid (b)(6) = <1.20 iu/l.No impact to patient management was reported.
Additional Manufacturer Narrative
The complaint investigation for falsely elevated 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.Return testing was not completed as returns were not available.Data and information provided by the customer were reviewed and support the complaint issue.Review of tracking and trending for the architect total b-hcg assay did not identify an increase in complaint activity related to the complaint issue.Additionally, an increase in complaint activity was not identified for reagent lot 68529ud00.Labeling was reviewed and sufficiently addresses the customer¿s issue.Device history review did not identify any nonconformances, potential nonconformances, or deviations associated with the lot number and complaint issue.The overall performance of architect total b-hcg reagent was reviewed using worldwide field data.Review shows that the median patient result for the lot is within established limits and comparable with other lots in the field, confirming no systemic issue for the lot.Based on the investigation, no systemic issue or deficiency of the architect total b-hcg reagent lot 68529ud00 was identified.All available patient information was included.Additional patient details are not available.

• Brand Name: ARCHITECT TOTAL B-HCG REAGENT KIT
• 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: 21970333
• Report Number: 3005094123-2025-00221
• Device Sequence Number: 8160710
• Product Code: DHA
• UDI-Device Identifier: 00380740014964
• UDI-Public: (01)00380740014964(17)251031(10)68529UD00
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 05/21/2025

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: 10/31/2025
• Device Catalogue Number: 07K78-25
• Device Lot Number: 68529UD00
• 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: 04/17/2025
• Supplement Date Received by Manufacturer: 05/20/2025
• Initial Report FDA Received Date: 05/06/2025
• Supplement Report FDA Received Date: 05/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/26/2024
• 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 INTGR, 01L86-40, (B)(6); ARC I1000SR INTGR, 01L86-40, (B)(6)
• Patient Sex: Unknown