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	01/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed a falsely elevated architect troponin result generated on an architect i1000sr analyzer for a male patient.Pid (b)(6), initial result = 268.3 pg/ml, repeat result = 8.6 pg/ml, repeat result (pid (b)(6) = 9.2 pg/ml and 9.6 pg/ml.There was no impact to patient management.
Additional Manufacturer Narrative
This issue was previously reported under mdr number 3005094123-2026-00063 under a different suspect device.After further evaluation, the architect i1000sr, list number 01l86-01, was identified as an additional suspect medical device.Service inspected the instrument, and multiple troubleshooting procedures were performed, including disinfection of instrument surfaces.Deposits were observed on the process path cover with ramp (rohs) and removed to resolve the issue.The instrument service history review revealed no additional tickets associated with discrepant/erratic patient 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 trending data associated with the process path cover with ramp (rohs) did not identify any trends.Additionally, a review of tracking and trending for the architect i1000sr did not identify any trends.Review of manufacturing documentation did not identify any non-conformances or potential non-conformances.Labeling was reviewed and adequately addressed the issue.Based on the investigation, no systemic issue or deficiency was identified for the architect i1000sr, (b)(6) nor the process path cover with ramp.

• 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: 24740888
• Report Number: 3016438761-2026-00177
• Device Sequence Number: 9165940
• Product Code: JJE
• UDI-Device Identifier: 00380740001537
• UDI-Public: (01)00380740001537
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/31/2026

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: 01L86-01
• 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: 03/19/2026
• Initial Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/26/2020
• 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, 81309UD00
• Patient Sex: Male