ROCHE 9180 ELECTROLYTE ANALYZER
Received May 28, 2025 · Event occurred Apr 30, 2025
Report 1823260-2025-01622 · MDR key 22094883
Device
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Output Problem
- Incorrect, Inadequate or Imprecise Result or Readings
- Output Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE NA ELECTRODE LOT NUMBER WAS REQUESTED BUT NOT PROVIDED. THE EXPIRATION DATE WAS REPORTED AS 12-DEC-2025. THE QCS WERE WITHIN THE SPECIFIED RANGES. THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THE INITIAL REPORTER RECEIVED A QUESTIONABLE SODIUM (NA) RESULT FROM TWO SAMPLES FROM THE SAME PATIENT TESTED ON THE ELECTROLYTE ANALYZER W/O STARTERKIT 9180. THE RESULT OF THE FIRST PATIENT SAMPLE WAS 123 MMOL/L WITH A DATA FLAG. THE RESULT OF THE SECOND PATIENT SAMPLE WAS 138 MMOL/L. THE REPORTER STATED THAT NO RESULT WAS ISSUED FOR THE PATIENT. THE REPORTER DID NOT STATE IF THE PATIENT SAMPLES WERE FROM THE SAME BLOOD COLLECTION.
Additional Manufacturer Narrative
THE FIELD SERVICE ENGINEER (FSE) PERFORMED TROUBLESHOOTING PROCEDURES ON THE ANALYZER AND INVESTIGATED THE CUSTOMER'S PREANALYTICAL HANDLING OF PATIENT SAMPLES; NO ISSUES WERE NOTED. THE INVESTIGATION REVIEWED THE MANUFACTURING DATA OF THE ELECTRODES; A MANUFACTURING DEFECT WAS RULED OUT. THE INVESTIGATION REVIEWED THE DATA SET PROVIDED BY THE CUSTOMER: THE CALIBRATION RESULT FOR ONE SODIUM (NA)STANDARD SOLUTION WAS ABOVE THE RANGE, WHILE THE VOLTAGE DIFFERENCES WERE WITHIN THE ALLOWED RANGE. THE QC RESULTS WERE WITHIN THE SPECIFIED RANGES. THERE WAS NO INDICATION OF A PERFORMANCE ISSUE WITH THE REAGENT. THE INVESTIGATION DETERMINED THAT THE EVENT WAS CONSISTENT WITH THE INTERPLAY BETWEEN SPECIFIC CORE COMPONENTS WITHIN THE SYSTEM (REFERENCE ELECTRODE, SODIUM NA ELECTRODE, REAGENT STANDARDS, AND REFERENCE SOLUTIONS). THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.