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

Catalog Number	01L86-01
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A final 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 falsely elevated architect stat high sensitive troponin-i results generated for a 20-year-old male patient sample.The following data was provided (customer¿s reference range 21-73 pg/ml): sample id (b)(6), initial result = 6000 pg/ml, repeat result = 5800 pg/ml.2 hours later a new sample was obtained and result = 0.4 pg/ml first sample also repeated at this time and result = 0.4 pg/ml.No impact to patient management was reported.
Event or Problem Description
The customer observed falsely elevated architect stat high sensitive troponin-i results generated for a 20-year-old male patient sample.The following data was provided (customer¿s reference range 21-73 pg/ml): sample id (b)(6), initial result = 6000 pg/ml, repeat result = 5800 pg/ml.2 hours later a new sample was obtained and result = 0.4 pg/ml first sample also repeated at this time and result = 0.4 pg/ml.No impact to patient management was reported.
Additional Manufacturer Narrative
Additional information in section d10 - concomitant product and h4 - device mfg date the field service representative (fsr) inspected the instrument, performed multiple troubleshooting procedures, and found the sample arc, probe was misaligned and had buffer crystals coating it.The arc, probe was replaced which resolved the issue.The instrument service history review for (b)(6) revealed no additional service tickets associated with discrepant/erratic results.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 tracking and trending of the architect i1000sr did not identify an increase in complaint activity associated with the complaint issue.A review of tracking and trending for the arc, probe did not identify an increase in complaint activity.A review of the manufacturing documentation did not identify any non-conformances or potential non-conformances associated with the complaint.Labeling was reviewed and found to adequately address the issue under review.Based on the investigation, no systemic issue or deficiency of the architect i1000sr for serial (b)(6), or the arc, probe, were identified.

• Brand Name: ARCHITECT I1000SR 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: 23179447
• Report Number: 3016438761-2025-00565
• Device Sequence Number: 21329940
• Product Code: JJE
• UDI-Device Identifier: 00380740001537
• UDI-Public: (01)00380740001537
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 10/24/2025

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: 01L86-01
• 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: 09/22/2025
• Supplement Date Received by Manufacturer: 10/16/2025
• Initial Report FDA Received Date: 09/30/2025
• Supplement Report FDA Received Date: 10/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/12/2010
• 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, PROBE, 08C94-47, UNKNOWN; RGT ARCH TROPONIN 100T, 03P25-27, 75703UD00; RGT ARCH TROPONIN 100T, 03P25-27, 75703UD00
• Patient Age: 20 YR
• Patient Sex: Male