AU5800 CHEMISTRY ANALYZER
Received Feb 19, 2026 · Event occurred Feb 12, 2026
Report 9612296-2026-00079 · MDR key 24394326
Device
Generic name
Analyzer, Chemistry (photometric, Discrete), For Clinical Use
Manufacturer
Beckman Coulter Mishima K.k.Catalog number
B96698
Product problems
- Low Test Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) EVALUATED THE AU5800 CHEMISTRY ANALYZER AND IDENTIFIED THE PROBABLE CAUSE AS A DEFECTIVE REFERENCE VALVE AND THE REFERENCE ELECTRODE. THE FSE REPLACED THE REFERENCE VALVE AND THE REFERENCE ELECTRODE. TO RESOLVE THE ISSUE. SECTION A2, A3, A4, A5 AND A6: INFORMATION NOT PROVIDED BY CUSTOMER. THE BECKMAN COULTER INTERNAL IDENTIFIER IS (B)(4).
Description of Event or Problem
THE CUSTOMER REPORTED THE GENERATION OF ERRONEOUSLY LOW SODIUM PATIENT RESULTS ON THEIR AU5800 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.