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	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed false initial reactive architect cmv igm and architect rubella igm results generated on the architect i2000sr instrument.The customer noted that the results were repeated on the siemens (electrochemiluminescence) or biomerieux (elisa) methodologies with negative results.There was no impact to patient management reported.
Additional Manufacturer Narrative
This report is being filed on an international product, list number 03m74 that has a similar product distributed in the us, list number 03m74, that is 510k exempt.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.All available patient information has been included.No additional patient details are available.
Additional Manufacturer Narrative
Section b3 - date of event: this section was updated from blank to 23-oct-2025.The field service representative (fsr) inspected the instrument and performed multiple troubleshooting steps, including cleaning and decontaminating the instrument, replacing and calibrating multiple parts.However, no definitive part was identified as the cause of the issue.A review of instrument service history for (b)(6) revealed that no additional discrepant result issues have been reported since the service activity was completed.A review of complaint and trending data for the architect i2000sr processing module did not identify any similar issues as described in this complaint.The device history record was reviewed, and no non-conformances or potential non-conformances were identified.Labeling was reviewed and found to be adequate.Based on the investigation, no systemic issue or deficiency was identified for the architect i2000sr processing module, serial number (b)(6).
Event or Problem Description
The customer observed false initial reactive architect cmv igm and architect rubella igm results generated on the architect i2000sr instrument.The customer noted that the results were repeated on the siemens (electrochemiluminescence) or biomerieux (elisa) methodologies with negative results.There was no impact to patient management 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: 23524062
• Report Number: 3016438761-2025-00667
• Device Sequence Number: 15738467
• Product Code: JJE
• UDI-Device Identifier: 00380740006235
• UDI-Public: (01)00380740006235
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 12/01/2025

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: 10/23/2025
• Supplement Date Received by Manufacturer: 11/25/2025
• Initial Report FDA Received Date: 11/11/2025
• Supplement Report FDA Received Date: 12/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/09/2015
• 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 RUB M RGT 100T, 06C18-25, 72122FZ00.; ARC RUB M RGT 100T, 06C18-25, 72122FZ00.; ARCHITECT CMV-IGM 500T, 06C16-30, 73090FZ00.; ARCHITECT CMV-IGM 500T, 06C16-30, 73090FZ00.
• Patient Sex: Unknown