MAUDE Adverse Event Report: ABBOTT LABORATORIES ARCHITECT I2000SR PROCESSING MODULE; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Catalog Number	03M74-02
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a1 patient identifier complete information: (b)(6).Further patient information, including discrepant results was provided.The investigation is ongoing.
Event or Problem Description
The customer observed falsely elevated architect stat high sensitive troponin-i results for two patient samples.(> 10 ng/l is considered abnormal, male: 4 to 12 ng/l, female: 4 to 10 ng/l the following results were provided: on (b)(6) 2025 sid (b)(6) 62-year-old male patient: initial result = 10.2 pg/ml, repeat result = <3.2 pg/ml on (b)(6) 2025 sid (b)(6) 57-year-old female patient: initial result = 11.2 pg/ml, repeat result = <3.2 pg/ml.No impact to patient management was reported.
Additional Manufacturer Narrative
The field service representative inspected the architect i2000sr processing module, performed multiple system checks and replaced various fluidics components.Data and information provided by the customer were reviewed.The instrument service history for the (b)(6) verified there were no additional service or complaint issues on or around the date this complaint was initiated that may have contributed to this issue.A review of complaint and trending data for the architect i2000sr processing module did not identify any similar issues related to the current issue.A review of the manufacturing documentation did not identify any non-conformances related to the current complaint.Labeling was reviewed and found to be adequate.Based on the available information, no systemic issue or deficiency of the architect i2000sr processing module for serial number (b)(6) was identified.
Event or Problem Description
The customer observed falsely elevated architect stat high sensitive troponin-i results for two patient samples.(> 10 ng/l is considered abnormal, male: 4 to 12 ng/l, female: 4 to 10 ng/l.The following results were provided: (b)(6) 2025 sid (b)(6), 62-year-old male patient: initial result = 10.2 pg/ml, repeat result = <3.2 pg/ml (b)(6) 2025 sid (b)(6), 57-year-old female patient: initial result = 11.2 pg/ml, repeat result = <3.2 pg/ml.No impact to patient management was reported.

• Brand Name: ARCHITECT I2000SR PROCESSING MODULE
• Common Device Name: ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
• Manufacturer (Section D): ABBOTT LABORATORIES; 1915 hurd drive; irving TX 75038
• Manufacturer (Section G): ABBOTT LABORATORIES; 1915 hurd drive; irving TX 75038
• Manufacturer Contact: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 23402236
• Report Number: 3016438761-2025-00635
• Device Sequence Number: 9946143
• Product Code: JJE
• UDI-Device Identifier: 00380740006235
• UDI-Public: (01)00380740006235
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 01/09/2026

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 Catalogue Number: 03M74-02
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2025
• Supplement Date Received by Manufacturer: 01/07/2026
• Initial Report FDA Received Date: 10/28/2025
• Supplement Report FDA Received Date: 01/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/28/2017
• 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
• Patient Sex: Unknown