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	12/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being filed on an international product, list number 01l86-40, that has the same product distributed in the us, list number 01l86-40, that is 510k exempt.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer reported a falsely elevated architect stat high sensitive troponin-i result generated by the architect i1000sr processing module for a male patient.The sample was retested, and subsequent results were within the normal range.The patient was referred to other hospitals, where troponin results were negative.The following data were provided: customer¿s cut off: 26 pg/ml sid (b)(6) initial architect stat high sensitive troponin-i result = 1652 pg/ml repeat results = 9.6, 7.8, and 8.1 pg/ml district hospital: troponin-i was negative (b)(6) hospital: troponin-i and troponin-c were both negative no impact to patient management was reported.
Event or Problem Description
The customer reported a falsely elevated architect stat high sensitive troponin-i result generated by the architect (b)(6) processing module for a male patient.The sample was retested, and subsequent results were within the normal range.The patient was referred to other hospitals, where troponin results were negative.The following data were provided: customer¿s cut off: 26 pg/ml.Sid (b)(6): initial architect stat high sensitive troponin-i result = 1652 pg/ml.Repeat results = 9.6, 7.8, and 8.1 pg/ml.(b)(6) hospital: troponin-i was negative.(b)(6) hospital: troponin-i and troponin-c were both negative.No impact to patient management was reported.
Additional Manufacturer Narrative
The instrument logs for the architect i1000sr processing module, serial number (b)(6) were reviewed, however, no definitive part could be determined as the cause of the issue.The instrument service history review revealed no additional 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 did not identify any trends for the architect i1000sr processing module with regards to the customer reported event.A review of the manufacturing documentation did not identify any issues associated with the complaint issue.Labeling was reviewed and sufficiently addresses the customer¿s issue.Based on the investigation, no systemic issue or deficiency of the architect i1000sr processing module, serial number (b)(6) was identified.

• 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: 23906068
• Report Number: 3016438761-2025-00770
• Device Sequence Number: 21315308
• Product Code: JJE
• UDI-Device Identifier: 00380740001544
• UDI-Public: (01)00380740001544
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 01/19/2026

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: 12/14/2025
• Supplement Date Received by Manufacturer: 01/16/2026
• Initial Report FDA Received Date: 12/29/2025
• Supplement Report FDA Received Date: 01/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/13/2019
• 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