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	12/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.A1 patient identifier: complete sample id is (b)(6).
Event or Problem Description
The customer reported falsely elevated architect stat high sensitive troponin-i and provided the following data: sample id (b)(6) - male patient.Customer reference range male: < 34 ng/l.The initial result was result was 198.1 ng/l.The sample was repeated and the resutls were 16.9 and 17.3 ng/l.There was no reported impact to patient management.
Event or Problem Description
The customer reported falsely elevated architect stat high sensitive troponin-i and provided the following data: sample id (b)(6) - male patient.Customer reference range male: < 34 ng/l.The initial result was result was 198.1 ng/l.The sample was repeated and the results were 16.9 and 17.3 ng/l.There was no reported impact to patient management.
Additional Manufacturer Narrative
H6 - adverse event problem: d code corrected.
Additional Manufacturer Narrative
The architect i2000sr, serial # (b)(6) was evaluated, and it was determined that the sample probe required replacement, which resolved the customer reported event.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.The instrument service history review revealed no additional complaints associated with the customer reported event.A review of tracking and trending did not identify an increase in complaint activity for the architect i2000sr, serial # (b)(6) or arc, probe with regards to the customer reported event.A review of the manufacturing documentation did not identify any issues for the arc, probe as it relates to the customer reported event.Labeling was reviewed and was found to address the customer reported event.Based on the available information, no systemic issue or deficiency was identified for the architect i2000sr, serial # (b)(6) or arc, probe.
Event or Problem Description
The customer reported falsely elevated architect stat high sensitive troponin-i and provided the following data: sample id (b)(6) - male patient.Customer reference range male: < 34 ng/l.The initial result was result was 198.1 ng/l.The sample was repeated and the results were 16.9 and 17.3 ng/l.There was no reported impact to patient management.

• 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: 23927527
• Report Number: 3016438761-2025-00779
• Device Sequence Number: 12989149
• Product Code: JJE
• UDI-Device Identifier: 00380740001544
• UDI-Public: (01)00380740001544
• 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,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: 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: 12/15/2025
• Supplement Date Received by Manufacturer: 01/21/2026; 01/26/2026
• Initial Report FDA Received Date: 12/30/2025
• Supplement Report FDA Received Date: 01/23/2026; 01/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/27/2023
• 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, 79392UD00; RGT ARCH TROPONIN 100T, 03P25-27, 79392UD00; RGT ARCH TROPONIN 100T, 03P25-27, 79392UD00
• Patient Sex: Male