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	10/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed a falsely elevated architect free t4 result generated for a 32-year-old female patient sample.The following data was provided (customer¿s reference range 9.01-19.05 pmol/l): sample id (b)(6) initial result = 35.34 pmol/l, repeat = 11.5 pmol/l.No impact to patient management was reported.
Additional Manufacturer Narrative
An evaluation is in process.A final report will be submitted when the evaluation is complete.Section a1 - patient identifier complete entry = (b)(6).Section e1 - initial reporter establishment name complete entry= (b)(6).Section e1 - address 1 complete entry = (b)(6).All available patient information was included.Additional patient details are not available.This report is being filed on an international product, list number 03m74-02, that has a similar product distributed in the us with the same list number, and a 510k/pma/bla number that¿s exempt.
Event or Problem Description
The customer observed a falsely elevated architect free t4 result generated for a 32-year-old female patient sample.The following data was provided (customer¿s reference range 9.01-19.05 pmol/l): sample id (b)(6) initial result = 35.34 pmol/l, repeat = 11.5 pmol/l.No impact to patient management was reported.
Additional Manufacturer Narrative
Additional information section h4 - device mfg date.The field service representative (fsr) inspected the instrument and performed troubleshooting.Crystals were found near the r2 pipettor, and the syringe assy was found to be leaking.The syringe assy was replaced which resolved the issue.The instrument service history review revealed one additional ticket associated with discrepant/erratic free t4 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 did not identify any similar issues as described in this complaint.Additionally, review of complaint and trending data associated with the syringe assy did not identify any trends.Review of the manufacturing documentation did not identify any non-conformances or potential non-conformances associated with the complaint issue.Labeling was reviewed and sufficiently addresses the customer¿s issue.Based on the investigation, no systemic issue or deficiency of the architect i2000sr, serial number (b)(6), or the syringe assy were identified.

• 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: 23393012
• Report Number: 3016438761-2025-00634
• Device Sequence Number: 15956355
• 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): 12/08/2025

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: 10/19/2025
• Supplement Date Received by Manufacturer: 12/05/2025
• Initial Report FDA Received Date: 10/27/2025
• Supplement Report FDA Received Date: 12/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/08/2013
• 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 FT4 500T (CN), 07K65-78, (B)(6) ; ARC FT4 500T (CN), 07K65-78, (B)(6)
• Patient Age: 32 YR
• Patient Sex: Female