AU5800 CHEMISTRY ANALYZER
Received Jul 30, 2026 · Event occurred Jul 7, 2026
Report 9612296-2026-00296 · MDR key 50091385
Device
Generic name
Analyzer, Chemistry (photometric, Discrete), For Clinical Use
Manufacturer
Beckman Coulter Inc.Model number
AU5800-10 CHEMISTRY ANALYZERCatalog number
B96697
Product problems
- Low Test Results
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
The customer reported generation of low Sodium (Na) patient results on their AU5800 Clinical Chemistry analyzer Ion Selective Electrode (ISE) unit (Product Number (P/N) B96697, Serial Number (SN) (b)(6) with poor repeatability. There was no report of change to treatment, injury, or death associated with this event. The customer did not provide patient data or demographics.
Additional Manufacturer Narrative
Beckman Coulter Field Service Engineer (FSE) evaluated the AU5800 Chemistry Analyzer and identified the failure mode as a defective sample syringe. The FSE replaced the sample syringe to resolve the issue. The customer was satisfied. No further action is required.Section A2, A4, and A5: Information not provided by customer.The Beckman Coulter internal identifier is (b)(4).