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	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2025
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.All available patient information was included.Additional patient details are not available.Section a1 patient identifier complete sid: (b)(6).
Event or Problem Description
The customer reported erratic architect ca 19-9xr results on a patient.It is unknown if the patient has pancreatic cancer.Results provided: ca 19-9 sid (b)(6): initial test 46.16 u/ml, second test 61.96 u/ml, third test 78.28 u/ml.Reference range 0-37 u/ml.No impact to patient management was reported.
Event or Problem Description
The customer reported erratic architect ca 19-9xr results on a patient.It is unknown if the patient has pancreatic cancer.Results provided: ca 19-9 sid (b)(6): initial test 46.16 u/ml, second test 61.96 u/ml, third test 78.28 u/ml.Reference range 0-37 u/ml.No impact to patient management was reported.
Additional Manufacturer Narrative
The architect i2000sr, serial # (b)(6) was evaluated, and it was determined that the sample probe required cleaning, which resolved the customer reported event.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.The instrument service history review revealed no additional complaints associated with the customer reported event.A review of tracking and trending did not identify an increase in complaint activity for the architect i2000sr, serial # (b)(6) or arc, probe with regards to the customer reported event.A review of the manufacturing documentation did not identify any issues for the arc, probe as it relates to the customer reported event.Labeling was reviewed and was found to address the customer reported event.Based on the available information, no systemic issue or deficiency was identified for the architect i2000sr, serial # (b)(6) or arc, probe.

• 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: 23814998
• Report Number: 3016438761-2025-00724
• Device Sequence Number: 13082856
• Product Code: JJE
• UDI-Device Identifier: 00380740006235
• UDI-Public: (01)00380740006235
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 01/14/2026

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: 12/01/2025
• Supplement Date Received by Manufacturer: 01/09/2026
• Initial Report FDA Received Date: 12/16/2025
• Supplement Report FDA Received Date: 01/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/07/2019
• 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 (CN), 02K91-74, 74575FP00.; ARC CA19-9XR 100T (CN), 02K91-74, 74575FP00.
• Patient Sex: Unknown