MAUDE Adverse Event Report: ABBOTT LABORATORIES ARCHITECT I1000SR PROCESSING MODULE (INTEGRATED); ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Catalog Number	01L86-40
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed falsely elevated architect stat high sensitive troponin-i results generated on the architect i1000sr instrument for two male patients.The following data was provided (customer reference range male <20 pg/ml): sid (b)(6), suspected mi, initial troponin result (b)(6) 2025, 16.97 pg/ml, repeated 25.54 and 14.87 pg/ml.Sid(b)(6), initial troponin result (b)(6) 2025, 8.52 pg/ml, repeated (b)(6) 2025 ,25.24 pg/ml rerun (b)(6) 2025, 8.50 pg/ml 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.A1 patient identifier: sample id's are (b)(6).
Additional Manufacturer Narrative
The field service representative (fsr) performed troubleshooting and discovered that the sample probe had not been replaced and/or calibrated in the last 365 days and the preventive maintenance was overdue.The fsr performed the preventive maintenance in addition to the modules internal decontamination.However, a definitive part or cause of the issue was not identified.The instrument service history review of the (b)(6) verified no subsequent falsely elevated stat troponin-i results were reported since the current issue was identified.A review of tracking and trending of the architect i1000sr did not identify any trends for the complaint issue.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.Based on the investigation, no systemic issue or deficiency of the architect i1000sr processing module for serial (b)(6) was identified.
Event or Problem Description
The customer observed falsely elevated architect stat high sensitive troponin-i results generated on the architect i1000sr instrument for two male patients.The following data was provided (customer reference range male <20 pg/ml): sid (b)(6), suspected mi, initial troponin result (b)(6) 2025 16.97 pg/ml, repeated 25.54 and 14.87 pg/ml.Sid (b)(6), initial troponin result (b)(6) 2025 8.52 pg/ml, repeated (b)(6) 2025 25.24 pg/ml rerun (b)(6) 2025 8.50 pg/ml.No impact to patient management was reported.

• Brand Name: ARCHITECT I1000SR PROCESSING MODULE (INTEGRATED)
• 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: 23372276
• Report Number: 3016438761-2025-00620
• Device Sequence Number: 8915877
• Product Code: JJE
• UDI-Device Identifier: 00380740001544
• UDI-Public: (01)00380740001544
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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): 11/17/2025

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: 01L86-40
• 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: 10/06/2025
• Supplement Date Received by Manufacturer: 11/13/2025
• Initial Report FDA Received Date: 10/23/2025
• Supplement Report FDA Received Date: 11/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/23/2016
• 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: RGT ARCH TROPONIN 100T, 03P25-27, 77549UD00; RGT ARCH TROPONIN 100T, 03P25-27, 77549UD00
• Patient Sex: Male