inforMED
MalfunctionJJE

DXC 700 AU CHEMISTRY ANALYZER

Received Nov 21, 2025 · Event occurred Nov 3, 2025

Report 9612296-2025-01016 · MDR key 23624463

Device

Generic name

Analyzer, Chemistry (photometric, Discrete), For Clinical Use

Catalog number

B86444

Product problems

  • Low Test Results
  • Low Test Results

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) EVALUATED THE DXC 700 AU CHEMISTRY ANALYZER AND IDENTIFIED THE PROBABLE CAUSE AS A LEAKING VALVE ASSEMBLY. THE FSE REPLACED THE SOLENOID VALVE 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 PATIENT RESULTS FOR RHEUMATOID FACTOR (RF), ALANINE AMINOTRANSFERASE (ALT), TOTAL BILIRUBIN (TBIL), CREATININE (CREA), UREA NITROGEN (BUN), AND POTASSIUM (K) ON THEIR DXC700AU 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.