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	12/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported a false positive architect stat troponin-i result for an 80-year-old male patient generated on the architect i1000sr analyzer.The following data was provided: sid (b)(6): initial result = 0.59 ng/ml (customer's normal range: < or = to 0.3 ng/ml) this result was reported out to the medical provider on (b)(6) 2025.Repeat testing on same analyzer result = < 0.01 ng/ml (negative) qc was in range at time of testing.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 reported a false positive architect stat troponin-i result for an 80-year-old male patient generated on the architect i1000sr analyzer.The following data was provided: sid (b)(6): initial result = 0.59 ng/ml (customer's normal range: < or = to 0.3 ng/ml) this result was reported out to the medical provider on (b)(6) 2025.Repeat testing on same analyzer result = < 0.01 ng/ml (negative) qc was in range at time of testing.There was no impact to patient management reported.
Additional Manufacturer Narrative
The customer replaced and calibrated the sample arc, probe to resolve the issue.The sample arc, probe was deemed the cause for the architect i1000sr, serial number (b)(6), generating the discrepant result.The system function was verified with a control run.Trending was reviewed for the analyzer and probe and did not identify any increase in complaints for the complaint issue.The device historical analysis was reviewed and determined no non-conformances or deviations were identified.Labeling was reviewed and adequately addresses the issue under review.Based on the investigation, no systemic issue or product deficiency was identified for the architect i1000sr, serial number (b)(6) or the sample arc, probe.

• 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: 23873242
• Report Number: 3016438761-2025-00758
• Device Sequence Number: 14788325
• Product Code: JJE
• UDI-Device Identifier: 00380740001544
• UDI-Public: (01)00380740001544
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 01/15/2026

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: 12/10/2025
• Supplement Date Received by Manufacturer: 01/13/2026
• Initial Report FDA Received Date: 12/22/2025
• Supplement Report FDA Received Date: 01/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/31/2018
• 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: 80 YR
• Patient Sex: Male