COBAS 8000 ISE 1800 MODULE
Received Dec 18, 2025 · Event occurred Dec 2, 2025
Report 1823260-2025-05213 · MDR key 23840148
Device
Generic name
Clinical Chemistry Analyzer
Manufacturer
Roche DiagnosticsCatalog number
05964075001
Lot number
ASKU
Product problems
- High Test Results
- High Test Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE COBAS 8000 COBAS ISE MODULE (DOUBLE) SERIAL NUMBER WAS (B)(6). THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THERE WAS AN ALLEGATION OF QUESTIONABLE RESULTS FROM THE COBAS 8000 COBAS ISE MODULE (DOUBLE). THIS MEDWATCH IS FOR THE SODIUM ASSAY. REFER TO THE MEDWATCHS WITH A1-PATIENT IDENTIFIERS FOR(B)(6) THE OTHER ASSAYS. THE INITIAL SODIUM RESULT WAS 150 MMOL/L, AND THE REPEAT RESULT WAS 137 MMOL/L. THE INITIAL POTASSIUM RESULT WAS 4.9 MMOL/L, AND THE REPEAT RESULT WAS 4.4 MMOL/L. THE INITIAL CHLORIDE RESULT WAS 117 MMOL/L, AND THE REPEAT RESULT WAS 104 MMOL/L. THE REPEAT RESULTS WERE BELIEVED TO BE CORRECT.
Additional Manufacturer Narrative
MEDWATCH FIELD D1-D4, G1, AND G4 WERE UPDATED. THE FIELD SERVICE ENGINEER CHANGED THE ISE SEALS. HE RAN AIR PURGES, MECHANISM CHECKS, AND PRECISION TESTING, WHICH ALL PASSED. THE CUSTOMER DID NOT HAVE ANY FURTHER ISSUES. THE INVESTIGATION DETERMINED THAT THE SERVICE ACTIONS RESOLVED THE ISSUE.