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	10/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complete information from section a1.Patient identifier: sid: (b)(6).This report is being filed on an international product, list number: 03m74 that has a similar product distributed in the us, list number: 03m74, that is 510k exempt.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer reported a falsely elevated architect stat highly sensitive troponin-i result generated on the architect i2000sr instrument for a 57-year-old male patient.The following data was provided (customer provided reference range was <26.2 pg/ml): on (b)(6) 2025, sid: (b)(6): initial result = 4026.2 pg/ml, repeat on (b)(6) 2025 = 2.7 pg/ml no impact to patient management was reported.
Additional Manufacturer Narrative
The field service representative (fsr) performed troubleshooting on the instrument and observed crystals in the wz2 solenoid valve.The fsr replaced the valve, manifold kit (rohs) which resolved the issue.The instrument service history of the (b)(6) did not identify any subsequent complaints for falsely elevated stat troponin patient results.A review of tracking and trending of the architect i2000sr did not identify any related trends for the current issue.A review of tracking and trending of the valve, manifold kit (rohs) did not identify any trends.A review of manufacturing documentation did not identify any non-conformances related to the complaint issue.The architect system operations manual provides adequate labeling with regards to maintenance and troubleshooting, the issue, including operational precautions and limitations; specimen handling recommendations and fluidic subsystems troubleshooting, and the system technology limitations and resolving the customer¿s issue.Based on the investigation, no systemic issue or deficiency of the architect i2000sr processing module, serial (b)(6) or the valve, manifold kit (rohs) was identified.
Event or Problem Description
The customer reported a falsely elevated architect stat high sensitive troponin-i result generated on the architect i2000sr instrument for a 57 year old male patient.The following data was provided (customer provided reference range was <26.2 pg/ml): (b)(6) 2025, sid (b)(6): initial result = 4026.2 pg/ml, repeat on (b)(6) 2025 = 2.7 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: 23524213
• Report Number: 3016438761-2025-00668
• Device Sequence Number: 13028076
• Product Code: JJE
• UDI-Device Identifier: 00380740006235
• UDI-Public: (01)00380740006235
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 12/11/2025

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 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: 11/01/2025
• Supplement Date Received by Manufacturer: 12/10/2025
• Initial Report FDA Received Date: 11/11/2025
• Supplement Report FDA Received Date: 12/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/26/2021
• 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 TROP 500T (CN), 03P25-77, 76364UD01; ARC TROP 500T (CN), 03P25-77, 76364UD01
• Patient Age: 57 YR
• Patient Sex: Male