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	12/06/2025
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.Complete information for section a1 patient identifier is sid (b)(6).
Event or Problem Description
The customer reported a falsely elevated architect stat troponin-i result generated by the architect i1000sr processing module for a 70-year-old female patient.The physician questioned the result.A new blood sample was tested yielded a normal result.The original sample was then retested, also producing a normal result.The following data was provided: customer¿s normal range: <0.05 ng/ml.Sid (b)(6) (first draw): (b)(6) 2025 @ 05:56 am initial result = 0.371 ng/ml, repeat result = 0.00 ng/ml.Sid (b)(6) (second draw): (b)(6) 2025 @ 08:46am initial result = 0.00 ng/ml, repeat result = 0.00 ng/ml no impact to patient management was reported.
Event or Problem Description
The customer reported a falsely elevated architect stat troponin-i result generated by the architect i1000sr processing module for a 70-year-old female patient.The physician questioned the result.A new blood sample was tested yielded a normal result.The original sample was then retested, also producing a normal result.The following data was provided: customer¿s normal range: <0.05 ng/ml.Sid (b)(6) (first draw): (b)(6) 2025 @ 05:56 am initial result = 0.371 ng/ml, repeat result = 0.00 ng/ml.Sid (b)(6) (second draw): (b)(6) 2025 @ 08:46am initial result = 0.00 ng/ml, repeat result = 0.00 ng/ml no impact to patient management was reported.
Additional Manufacturer Narrative
The field service representative (fsr) inspected the instrument and performed extensive troubleshooting, which included replacing, cleaning and adjusting multiple parts.However, a definitive part was not identified.A review of instrument service history for serial number (b)(6) revealed that no additional discrepant result issues have been reported since the service activity was completed.A review of tracking and trending data did not identify any trends for the architect i1000sr processing module with regards to the current issue.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 i1000sr processing module, serial number (b)(6).

• 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: 23881934
• Report Number: 3016438761-2025-00764
• Device Sequence Number: 18543054
• Product Code: JJE
• UDI-Device Identifier: 00380740001544
• UDI-Public: (01)00380740001544
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 01/21/2026

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: 12/06/2025
• Supplement Date Received by Manufacturer: 01/15/2026
• Initial Report FDA Received Date: 12/23/2025
• Supplement Report FDA Received Date: 01/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/13/2013
• 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 TROP RGT, 02K41-27, 66709UN25; ARC TROP RGT, 02K41-27, 66709UN25
• Patient Age: 70 YR
• Patient Sex: Female