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	Patient Data Problem (3197)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2025
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.
Event or Problem Description
The customer reported a sample barcode was misread by the architect i2000sr sid (b)(6) generated by the lis was recognized as sid 1 by the analyzer which overrode the previous results for sid 1.No impact to patient management was reported.
Event or Problem Description
The customer reported a sample barcode was misread by the architect i2000sr sid (b)(6) generated by the lis was recognized as sid 1 by the analyzer which overrode the previous results for sid 1.No impact to patient management was reported.
Additional Manufacturer Narrative
The customer repeated the sample as a single patient run, the sample barcode reader read the tube correctly.The barcode reader sid (rohs) - i2000sr/c8000/c16000 (part number 7-35009170-01) was cleaned by the customer with service assistance and deemed the likely cause.Pictures depicting the observed sample barcoded tube were provided and show that the label is slightly angled with printed characters directly beneath the barcode as well as white areas in the black bars, indicating label quality was not optimal.Additionally, issues with the lab¿s lis system could not be ruled out.The service history of the (b)(6) verifies no subsequent incorrectly reading sample barcode issues have been reported since the current issue was identified.The product labeling review found architect system operations manual adequately address operational precautions and limitations and barcode label requirements.A review of complaints and trending data for the architect i2000sr processing module did not identify any similar issues as described in this complaint.Additionally, review of complaints and trending data associated with the barcode reader did not identify an increase in complaint activity.A review of the manufacturing documentation did not identify any issues associated with the customer¿s observation.A review of labeling concluded that the issue is sufficiently addressed.Based on the investigation, no product deficiency was identified for the architect i2000sr processing module, serial number (b)(6) or barcode reader.

• 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: 23847736
• Report Number: 3016438761-2025-00740
• Device Sequence Number: 18534880
• 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): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2026

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: 12/03/2025
• Supplement Date Received by Manufacturer: 02/10/2026
• Initial Report FDA Received Date: 12/19/2025
• Supplement Report FDA Received Date: 02/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2014
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown