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

Catalog Number	03M74-01
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Service was replacing the reagent 2 pressure monitor sensor when a drop of liquid accidently fell on bd, pressure monitor (rohs)_part number 7-78585-04 causing the part to smoke.The analyzer was disconnected from the power supply /shut down when the smoke was observed and there was no injury to personnel reported.No fire was seen, nor any damage other parts of the instrument.Service replaced the bd, pressure monitor (rohs)_part number 7-78585-04 and deemed the part the likely cause for the smoke.A review of the architect i2000sr, serial # (b)(6) service history, revealed no additional issues of smoke observed due to liquid accidently dropped on a part.A review of tracking and trending did not find increased complaint activity for the bd, pressure monitor (rohs)_part number 7-78585-04 with regards to the complaint issue.The device history record was reviewed and identified no non-conformances or deviations associated with the complaint issue.The 2025 ul certification memo indicates that abbott diagnostic equipment and accessories are certified to the appropriate safety standards, and adequate protection is provided for the operator against spread of fire from the equipment.The smoke was limited to the bd, pressure monitor (rohs)_part number 7-78585-04, to liquid accidently dropped on the part; no other parts of the module were affected.Labeling was reviewed and adequately addresses the issue under review.A malfunction was not identified.Based on the information within the complaint record, the part met performance specifications and performed as intended at the customer site and no systemic issue or deficiencies were identified.The issue occurred when the liquid accidently fell on the bd, pressure monitor (rohs)_part number 7-78585-04 causing the part to smoke.
Event or Problem Description
The customer reported error message error code 3350, unable to process test, aspiration error for (r2 pipettor) at (r2 inner reagent) on the architect i2000 serial number (b)(6).The abbott field service engineer(fse) as part of troubleshooting replaced the r2 pm sensor.While replacing the sensor, a drop of liquid accidentally fell on the pm board causing it to smoke.The fse turned the power off and replaced the pm sensor board.The fse then turned the power back on.There is no further smoke or smell coming from the instrument.Fse performed a startup, flush fluids, pm sensor test for all locations and lls test for all locations.All tests passed.Instrument ready for use.No impact to patient management was reported.No injuries to the users were reported.

• Brand Name: ARCHITECT I2000SR
• 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: 21619948
• Report Number: 3016438761-2025-00162
• Device Sequence Number: 12868227
• Product Code: JJE
• UDI-Device Identifier: 00380740023386
• UDI-Public: (01)00380740023386
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/17/2025

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: 03M74-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/26/2025
• Initial Report FDA Received Date: 03/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2012
• 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: BD, PRESSURE MONITOR (ROHS), 7-78585-04, UNKNOWN
• Patient Sex: Unknown