MAUDE Adverse Event Report: BECKMAN COULTER, INC. IMMAGE 800; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Model Number	IMMAGE 800 FINAL ASSY - PKGD
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	12/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Beckman coulter field service engineer (fse) evaluated the immage chemistry analyzer and identified the probable cause as a damaged reagent probe and bent mixer paddle.The fse replaced the reagent probe and mixer paddle to resolve the issue.Section a2, a3, a4, a5 and a6: information not provided by customer.The beckman coulter internal identifier is (b)(4).
Event or Problem Description
The customer reported the generation of false patient results on their immage 800 clinical chemistry analyzer.There was no report of change to treatment, injury, or death associated with event.The customer did not provide patient data or demographics.
Additional Manufacturer Narrative
Upon further evaluation, this event is a non-reportable event due to the low worst-case severity for the immage instrument of permanent injury and probability of harm of remote.

• Brand Name: IMMAGE 800
• Common Device Name: ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
• Manufacturer (Section D): BECKMAN COULTER, INC.; 250 s. kraemer blvd.; brea CA 92821
• Manufacturer (Section G): BECKMAN COULTER INC; 250 s. kraemer blvd.; brea CA 92821
• Manufacturer Contact: shama agtey ; 1000 lake hazeltine drive; chaska, MN 55318 ; 9524916938
• MDR Report Key: 24024228
• Report Number: 2050012-2026-00001
• Device Sequence Number: 10719738
• Product Code: JJE
• UDI-Device Identifier: 15099590265403
• UDI-Public: (01)15099590265403(11)080227
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K103842
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2026

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 Model Number: IMMAGE 800 FINAL ASSY - PKGD
• Device Catalogue Number: A15445
• 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: 12/15/2025
• Supplement Date Received by Manufacturer: 12/15/2025
• Initial Report FDA Received Date: 01/09/2026
• Supplement Report FDA Received Date: 01/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/27/2008
• 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