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

Catalog Number	03M74-02
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2026
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.All available patient information was included.Additional patient details are not provided.
Event or Problem Description
The customer reported a falsely elevated architect ca19-9xr result for a 66 year old female diagnosed with pancreatic cancer.The following data was provided: (b)(6) 2026, sid (b)(6): initial result = 118.59 u/ml, repeat = 49.28 u/ml.No impact to patient management was reported.
Additional Manufacturer Narrative
Troubleshooting performed by an abbott service representative included replacement of the arc pump body 100microl which resolved the issue.Issue resolution was verified with passing qc runs.No additional discrepant result issues have been reported since the service activity was completed.The service history of the architect i2000sr processing module, serial number: (b)(6) returned no additional tickets for discrepant patient results on or around the date this complaint was initiated that may have contributed to this issue.A review of tracking and trending data did not identify any trends related to the complaint issue.A review of the corrective and preventive actions system did not identify any nonconformance's or deviations for the architect i2000sr processing module or arc pump body 100microl.A review of the product labeling concluded that the issue is sufficiently addressed.The architect system operations manual provides information regarding the troubleshooting of erratic/discrepant results and on the removal, replacement, and verification of the arc pump body 100microl.Based on the investigation no systemic issue or product deficiency was identified.
Event or Problem Description
The customer reported a falsely elevated architect ca19-9xr result for a 66-year-old female diagnosed with pancreatic cancer.The following data was provided: on (b)(6) 2026, sid: (b)(6): initial result = 118.59 u/ml, repeat = 49.28 u/ml no impact to patient management was reported.

• Brand Name: ARCHITECT I2000SR PROCESSING MODULE
• 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: 24597749
• Report Number: 3016438761-2026-00134
• Device Sequence Number: 15595641
• Product Code: JJE
• UDI-Device Identifier: 00380740006235
• UDI-Public: (01)00380740006235
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 03/25/2026

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: 03M74-02
• 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: 03/03/2026
• Supplement Date Received by Manufacturer: 03/23/2026
• Initial Report FDA Received Date: 03/13/2026
• Supplement Report FDA Received Date: 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/29/2014
• 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 CA19-9XR 100T, 02K91-32, 79760FP00.; ARC CA19-9XR 100T, 02K91-32, 79760FP00.
• Patient Age: 66 YR
• Patient Sex: Female