MAUDE Adverse Event Report: ABBOTT LABORATORIES ARCHITECT I2000SR PROCESSING MODULE, REFURBISHED; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Catalog Number	03M74-84
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed a falsely elevated architect stat high sensitivity troponin-i for one patient.The patient sample was repeated on the same instrument with lower results.The following results were provided: reference ranges: females <17 ng/l, males <35 ng/l.(b)(6) 2026, sid (b)(6), 85-year-old female, initial troponin result= 24 ng/l; repeat result= <3.5 ng/l there was no impact to patient management reported.
Additional Manufacturer Narrative
An evaluation is in process.A follow-up 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 a falsely elevated architect stat high sensitivity troponin-i for one patient.The patient sample was repeated on the same instrument with lower results.The following results were provided: reference ranges: females <17 ng/l, males <35 ng/l.On (b)(6) 2026, sid (b)(6), 85-year-old female, initial troponin result= 24 ng/l; repeat result= <3.5 ng/l there was no impact to patient management reported.
Additional Manufacturer Narrative
The customer replaced and calibrated the architect stat probe to resolve the issue.The system function was verified with a control run.A review of instrument service history for (b)(6) 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 complaint and trending data for the architect i2000sr processing module did not identify any similar issues as described in this complaint.Additionally, a review of complaint and trending data associated with the architect stat probe did not identify an increase in complaint activity.A review of the manufacturing documentation did not identify any non-conformances associated with the complaint issue.Labeling was reviewed and found to be adequate.Based on the investigation, no systemic issue or deficiency was identified for the architect i2000sr processing module, serial number (b)(6), or the architect stat probe.

• Brand Name: ARCHITECT I2000SR PROCESSING MODULE, REFURBISHED
• 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: 24202660
• Report Number: 3016438761-2026-00051
• Device Sequence Number: 9809854
• Product Code: JJE
• UDI-Device Identifier: 00380740107222
• UDI-Public: (01)00380740107222
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2026

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: 03M74-84
• 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: 01/08/2026
• Supplement Date Received by Manufacturer: 02/06/2026
• Initial Report FDA Received Date: 01/28/2026
• Supplement Report FDA Received Date: 02/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/09/2016
• 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 TROPONIN HS RGT 500, 02R98-35, (B)(6); ARC TROPONIN HS RGT 500, 02R98-35, (B)(6); ARC, PROBE, 08C94-47, UNKNOWN; ARC, PROBE, 08C94-47, UNKNOWN
• Patient Age: 85 YR
• Patient Sex: Female