ROCHE 9180 ELECTROLYTE ANALYZER
Received Jun 30, 2025 · Event occurred Jun 6, 2025
Report 1823260-2025-01977 · MDR key 22356701
Device
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Low Test Results
- Incorrect, Inadequate or Imprecise Result or Readings
- Low Test Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE ROCHE 9180 SODIUM ELECTRODE LOT NUMBER IS 31245047. QC LEVELS 1 AND 2 WERE WITHIN THE SPECIFIED RANGES. THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THE INITIAL REPORTER RECEIVED QUESTIONABLE ROCHE 9180 SODIUM ELECTRODE RESULTS FROM TWO PATIENT SAMPLES TESTED ON THE ELECTROLYTE ANALYZER W/O STARTERKIT 9180. PATIENT SAMPLE 1 THE INITIAL RESULT WAS 113 MMOL/L WITH A DATA FLAG. THE REPEAT RESULT WAS 139 MMOL/L. PATIENT SAMPLE 2 THE HIGH RESULT WAS 141 MMOL/L. THE LOW RESULT WAS 115 MMOL/L WITH A DATA FLAG. THE LOW RESULTS WERE INCONSISTENT WITH THE PATIENTS' CLINICAL STATE. THE QUESTIONABLE RESULTS WERE NOT REPORTED OUTSIDE THE LABORATORY.
Additional Manufacturer Narrative
IN THE INITIAL MEDWATCH, THE FIRST LINE OF B5 DESCRIBE EVENT OR PROBLEM SHOULD HAVE BEEN: "THE INITIAL REPORTER RECEIVED QUESTIONABLE ROCHE 9180 SODIUM ELECTRODE RESULTS FROM TWO PATIENT SAMPLES TESTED ON THE ROCHE 9180 ELECTROLYTE ANALYZER W/O STARTERKIT 9180." INSTEAD OF: "THE INITIAL REPORTER RECEIVED QUESTIONABLE ROCHE 9180 SODIUM ELECTRODE RESULTS FROM TWO PATIENT SAMPLES TESTED ON THE ELECTROLYTE ANALYZER W/O STARTERKIT 9180." THE CUSTOMER USED A DIAMOND DIAGNOSTICS (DD REF ELECTRODE) FOR THE ROCHE 9180 ELECTROLYTE ANALYZER. THE FIELD SERVICE ENGINEER REPLACED THE REFERENCE AND SODIUM ELECTRODES, THE ELECTRODE HOUSING, AND THE ANALYZER'S FLUID, WASTE, AND CALIBRATOR PACK. THE INVESTIGATION REVIEWED THE QCS; QC LEVELS 1 AND 2 RESULTS WERE WITHIN THE SPECIFIED RANGES. THE ROOT CAUSE OF THE ISSUE WAS RELATED TO A REFERENCE ELECTRODE MANUFACTURED BY DIAMOND DIAGNOSTICS (DD REF ELECTRODE) USED WITH THE 9180 ELECTROLYTE ANALYZER. THE REFERENCE ELECTRODE USED (DD REF ELECTRODE) IS COVERED BY A ROCHE-INITIATED RECALL. CUSTOMERS USING THE DD REF ELECTRODE WERE INSTRUCTED TO IMMEDIATELY STOP USING THE SODIUM (NA) RESULTS FROM THEIR 9180 ANALYZER. THE AFFECTED REFERENCE ELECTRODE WAS NOT DISTRIBUTED IN THE UNITED STATES. CUSTOMERS IN THE UNITED STATES USE THE ROCHE REFERENCE ELECTRODE AND THE REFERENCE ELECTRODE HOUSING. NO FURTHER ACTION IS NEEDED FOR CUSTOMERS IN THE UNITED STATES.