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	02/01/2026
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.Section a patient information: refer to section b5 for complete patient information.This report is being filed on an international product, list number 01l86-40 that has a similar product distributed in the us, list number 01l86, that is 510k exempt.
Event or Problem Description
The customer observed elevated highly sensitive troponin-i results when processing on the architect i1000sr processing module.On (b)(6) 2026, sample id (b)(6) generated 55.8 pg/ml, rerun 2.2 pg/ml.Customer reference range: male < 12 pg/ml and female < 10 pg/ml.Additional patient information was not provided.No impact to patient management was reported.
Additional Manufacturer Narrative
The complaint investigation for falsely elevated architect stat troponin-i results on the architect i1000sr, serial number (b)(6), included a review of complaint text, a search for similar complaints, trending data, labeling, and device history records.The customer service representative reviewed the instrument logs and determined the arc tbg/sn tp wz, list number 08c94-90, was broken and the customer replaced it, which resolved the customer¿s complaint.No subsequent issues have been reported.A review of the instrument history revealed no contributing factors described in this complaint.A review of labeling and historical data was done, and both were adequate, with no trends found.Based on all available information and abbott diagnostics' complaint investigation, no systemic issue or deficiency was identified.
Event or Problem Description
The customer observed elevated highly sensitive troponin-i results when processing on the architect i1000sr processing module.On (b)(6) 2026, sample id (b)(6) generated 55.8 pg/ml, rerun 2.2 pg/ml.Customer reference range: male < 12 pg/ml and female < 10 pg/ml.Additional patient information was not provided.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: 24442327
• Report Number: 3016438761-2026-00106
• Device Sequence Number: 10211971
• Product Code: JJE
• UDI-Device Identifier: 00380740001544
• UDI-Public: (01)00380740001544
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 03/24/2026

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: 02/07/2026
• Supplement Date Received by Manufacturer: 03/19/2026
• Initial Report FDA Received Date: 02/25/2026
• Supplement Report FDA Received Date: 03/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/17/2020
• 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, (B)(6); RGT ARCH TROPONIN 100T, 03P25-27, (B)(6)
• Patient Sex: Unknown