ROCHE 9180 ELECTROLYTE ANALYZER
Received Apr 23, 2025 · Event occurred Mar 28, 2025
Report 1823260-2025-01244 · MDR key 21892143
Device
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE SODIUM ELECTRODE LOT NUMBER AND EXPIRATION DATE WERE REQUESTED, BUT NOT PROVIDED. THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR TWO PATIENT SAMPLES TESTED WITH THE SODIUM ELECTRODE ON A ROCHE 9180 ELECTROLYTE ANALYZER. THE FIRST SAMPLE INITIALLY RESULTED IN A SODIUM VALUE OF 129 MMOL/L AND IT REPEATED AS 139 MMOL/L. THE SAMPLE WAS REPEATED ON A SECOND ANALYZER, RESULTING IN A VALUE OF 140 MMOL/L. THE SECOND SAMPLE INITIALLY RESULTED IN A SODIUM VALUE OF 145 MMOL/L WITH A DATA FLAG ON (B)(6) 2025. THE SAMPLE WAS REPEATED, RESULTING IN A SODIUM VALUE OF 132 MMOL/L WITH A DATA FLAG.
Additional Manufacturer Narrative
QUALITY CONTROLS WERE WITHIN ACCEPTABLE RANGES. CALIBRATION DATA PROVIDED FROM (B)(6) 2025 WAS ACCEPTABLE. A REVIEW OF ALARM INFORMATION SHOWED POWER FAIL ALARMS OCCURRING ON (B)(6) 2025. A NETWORK CAMERA ERROR OCCURRED ON (B)(6) 2025. AN OBSTRUCTION ERROR OCCURRED ON (B)(6) 2025. A "NOT CALIBRATED" ERROR OCCURRED ON (B)(6) 2025. A REVIEW OF CERTIFICATES OF ANALYSIS FOR THE PROVIDED LOT NUMBERS CONFIRM THAT ALL COMPONENTS PASSED THE INTERNAL MANUFACTURING AND QUALITY CONTROL CHECKS, MEETING ALL REQUIRED SPECIFICATIONS. A MANUFACTURING DEFECT CAN BE RULED OUT AS THE CAUSE OF THE REPORTED ISSUE. INITIAL INVESTIGATION FINDINGS SUGGEST THAT THE PROBLEM LIKELY STEMS FROM THE INTERPLAY BETWEEN SPECIFIC CORE COMPONENTS WITHIN THE SYSTEM (REFERENCE ELECTRODE, NA ELECTRODE), ALONG WITH POTENTIAL DEFICIENCIES IN THE MAIN INSTRUMENT'S OPERATION.
Additional Manufacturer Narrative
THE CUSTOMER CHANGED THE SODIUM ELECTRODE AND STARTED USING ELECTRODE LOT NUMBER 31245147. THE CUSTOMER STATED THAT THE ISSUE PERSISTS WITH THIS NEW ELECTRODE.
Additional Manufacturer Narrative
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 SODIUM (NA) RESULTS FROM THEIR 9180 ANALYZERS. THE AFFECTED REFERENCE ELECTRODE WAS NOT DISTRIBUTED IN THE UNITED STATES. CUSTOMERS IN THE UNITED STATES USE ROCHE REFERENCE ELECTRODE AND REFERENCE ELECTRODE HOUSING. NO FURTHER ACTION IS NEEDED FOR CUSTOMERS IN THE UNITED STATES.