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	01/14/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed false positive architect total bhcg results.On (b)(6) 2026 sid (b)(6) (30 year old female) positive (80 miu/ml) redraw in a different lab was negative.On (b)(6) 2026 sid (b)(6) (23 year old female) positive (209 miu/ml) redraw in a different lab was negative.On (b)(6) 2026 sid (b)(6) (34 year old female) positive, redraw in a different lab was negative.The patients are on iud/birth control.No impact to patient management was reported.
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Section a patient information: refer to section b5 for complete patient information.
Additional Manufacturer Narrative
The data and information provided by the customer were reviewed and supported the complaint issue without indication of any additional issues.A search for similar complaints did not identify an increase in complaint activity for lot 73561ud00.A review of tracking and trending for the architect total -hcg assay did not identify any trends related to the complaint issue.A review of the device history record did not identify any non-conformances, potential non-conformances or deviations with lot number 73561ud00 and the complaint issue.The overall performance of architect total -hcg reagents in the field was reviewed using data gathered from customers worldwide.The median patient result for the complaint lot is within established limits and comparable with other lots in the field, confirming no systemic issue for the lot.A review of labeling was performed and found to sufficiently address the customer¿s issue.Per product labeling, for diagnostic purposes, hcg results should always be used in conjunction with other data; e.G., patient¿s medical history, symptoms, results of other tests, clinical impressions, etc.If the hcg level is inconsistent with, or unsupported by, clinical evidence, results should be confirmed by an alternate hcg method.Additionally, as with any immunochemical reaction, unknown interferences from medications or endogenous substances may affect results.Interfering substances (such as heterophilic antibodies, non-specific proteins, or hcg-like substances) may falsely depress or falsely elevate results.These interfering substances may cause false results over the entire range of the assay, not just at low levels.Based on our investigation, no systemic issue or deficiency was identified with the architect total -hcg reagent, lot number 73561ud00.
Event or Problem Description
The customer observed false positive architect total bhcg results.(b)(6) 2026; sid (b)(6); (30-year-old female); positive (80 miu/ml); redraw in a different lab was negative.(b)(6) 2026; sid (b)(6); (23-year-old female); positive; (209 miu/ml); redraw in a different lab was negative.(b)(6) 2026; sid (b)(6); (34-year-old female); positive, redraw in a different lab was negative.The patients are on iud/birth control.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: 24270161
• Report Number: 3005094123-2026-00059
• Device Sequence Number: 15958042
• Product Code: DHA
• UDI-Device Identifier: 00380740014964
• UDI-Public: (01)00380740014964(17)260402(10)73561UD00
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2026

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: 04/02/2026
• Device Catalogue Number: 07K78-25
• Device Lot Number: 73561UD00
• 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: 01/19/2026
• Supplement Date Received by Manufacturer: 04/01/2026
• Initial Report FDA Received Date: 02/05/2026
• Supplement Report FDA Received Date: 04/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2025
• 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 MOD, 01L86-01, (B)(6); ARC I1000SR MOD, 01L86-01, (B)(6)
• Patient Sex: Unknown