MalfunctionJFP
ROCHE 9180 ELECTROLYTE ANALYZER
Received Mar 4, 2025 · Event occurred Feb 6, 2025
Report 1823260-2025-00606 · MDR key 21513656
Device
Product problems
- Output Problem
- Output Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE ELECTRODE LOT NUMBER AND EXPIRATION DATE WERE NOT PROVIDED. THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THE INITIAL REPORTER RECEIVED A QUESTIONABLE LITHIUM ASSAY RESULT FROM ONE PATIENT SAMPLE TESTED ON THE ELECTROLYTE ANALYZER W/O STARTERKIT 9180. ON (B)(6)2025, THE INITIAL RESULT WAS 1.0 MMOL/L. ON (B)(6)2025, THE REPEAT RESULT WAS 6.0 MMOL/L.
Additional Manufacturer Narrative
THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM BASED ON THE INFORMATION PROVIDED. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.