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	12/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complete entry for section a1 - patient identifier: (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 false positive architect stat troponin-i for a 32-year-old female.The following results were provided (reference range <0.04 ng/ml): 16dec2025, sid (b)(6), initial troponin result= 1.38 ng/ml.Another sample was tested with a result= 0.021 ng/ml.The original sample was repeated with results= 0.024 ng/ml, 0.014 ng/ml, 0.010 ng/ml, 0.012 ng/ml, <0.010 ng/ml, and 0.014 ng/ml.There was no impact to patient management reported.
Additional Manufacturer Narrative
The complaint investigation for a falsely elevated architect stat troponin-i result, on the architect i2000sr, serial number (b)(6), included a review of complaint text, a search for similar complaints, trending data, labeling, and device history records.The customer repeating the sample was the only troubleshooting performed, so the architect i2000sr, serial number (b)(6), was deemed the subject of the investigation.No subsequent issues have been reported.A review of the instrument history revealed no contributing factors described in this complaint.A review of labeling and historical data was done, and both were adequate, with no trends found.Based on all available information and abbott diagnostics' complaint investigation, no systemic issue or deficiency was identified.
Event or Problem Description
The customer observed a false positive architect stat troponin-i for a 32-year-old female.The following results were provided (reference range 0.04 ng/ml): (b)(6) 2025, sid (b)(6), initial troponin result= 1.38 ng/ml.Another sample was tested with a result= 0.021 ng/ml.The original sample was repeated with results= 0.024 ng/ml, 0.014 ng/ml, 0.010 ng/ml, 0.012 ng/ml, 0.010 ng/ml, and 0.014 ng/ml.There was no impact to patient management 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: 23959876
• Report Number: 3016438761-2026-00005
• Device Sequence Number: 9473787
• Product Code: JJE
• UDI-Device Identifier: 00380740006235
• UDI-Public: (01)00380740006235
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2026

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: 12/17/2025
• Supplement Date Received by Manufacturer: 01/21/2026
• Initial Report FDA Received Date: 01/05/2026
• Supplement Report FDA Received Date: 01/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/02/2018
• 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 RGT, 02K41-27, 85694UN25; ARC TROP RGT, 02K41-27, 85694UN25
• Patient Age: 32 YR
• Patient Sex: Female