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	05/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complete information for section a patient information, 1.Patient identifier = sid= (b)(6).All available patient information was included.Additional patient details are not available.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer observed false negative architect b-hcg results on a pregnant patient.The results provided were: on (b)(6) 2025 sid (b)(6) initial=1.32 miu/ml (negative, or= 5.00 miu/ml) /repeated on (b)(6) 2025=2801.71 miu/ml (positive or =25.00 miu/ml) /repeated on card test=positive there was no reported impact to patient management.
Event or Problem Description
The customer observed false negative architect b-hcg results on a pregnant patient.The results provided were: on (b)(6) 2025, sid: (b)(6) initial=1.32 miu/ml (negative=< or=5.00 miu/ml) /repeated on (b)(6) 2025=2801.71 miu/ml (positive= > or =25.00 miu/ml) /repeated on card test=positive there was no reported impact to patient management.
Additional Manufacturer Narrative
The complaint evaluation 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 architect total b-hcg reagent, lot: 68529ud00.Return testing was not completed as returns were not available.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional 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.Historical performance of the architect total b-hcg reagents in the field was reviewed using data gathered via abbottlink from customers worldwide.The number of standard deviations to the cut-off for the negative population and median values for the complaint lot are within the established limits and comparable to the historical reagent lot performance.Therefore, no unusual reagent lot performance was identified.Device history record review did not identify any non-conformance's or deviations with the complaint lot and complaint issue.A review of the product labeling concluded that the issue is sufficiently addressed.Based on the investigation no product deficiency was identified for the architect total b-hcg reagent, lot: 68529ud00.

• 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: 22158959
• Report Number: 3005094123-2025-00286
• Device Sequence Number: 12988339
• Product Code: DHA
• UDI-Device Identifier: 00380740014964
• UDI-Public: (01)00380740014964(17)251031(10)68529UD00
• 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): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2025

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: 05/21/2025
• Supplement Date Received by Manufacturer: 08/01/2025
• Initial Report FDA Received Date: 06/06/2025
• Supplement Report FDA Received Date: 08/01/2025
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARC I1000SR MOD, 01L86-01, I1SR60760.; ARC I1000SR MOD, 01L86-01, I1SR60760.
• Patient Sex: Unknown