ROCHE 9180 ELECTROLYTE ANALYZER
Received Feb 25, 2025 · Event occurred Feb 3, 2025
Report 1823260-2025-00540 · MDR key 21458451
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 NA ELECTRODE LOT NUMBER IS NS 31244047. THE EXPIRATION DATE WAS NOT PROVIDED. THE CUSTOMER USED A NON-ROCHE REFERENCE ELECTRODE WITH THE ROCHE REFERENCE ELECTRODE HOUSING. THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THE INITIAL REPORTER RECEIVED QUESTIONABLE SODIUM (NA) RESULTS FROM MULTIPLE PATIENT SAMPLES TESTED ON THE ELECTROLYTE ANALYZER W/O STARTERKIT 9180. ONE EXAMPLE OF DISCREPANT RESULTS WAS PROVIDED: THE HIGH RESULT WAS 130 MMOL/L. THE LOW RESULT WAS 117 MMOL/L.
Additional Manufacturer Narrative
IN B5 DESCRIBE EVENT OR PROBLEM, THE FIRST LINE SHOULD HAVE BEEN: "THE INITIAL REPORTER RECEIVED QUESTIONABLE SODIUM ELECTRODE RESULTS FROM MULTIPLE PATIENT SAMPLES TESTED ON THE ROCHE 9180 ELECTROLYTE ANALYZER." INSTEAD OF : "THE INITIAL REPORTER RECEIVED QUESTIONABLE SODIUM (NA) RESULTS FROM MULTIPLE PATIENT SAMPLES TESTED ON THE ELECTROLYTE ANALYZER W/O STARTERKIT 9180." THE FIELD SERVICE ENGINEER CONFIRMED THAT THE EVENT WAS CAUSED BY THE INCORRECTLY TIGHTENED THIRD-PARTY/NON-ROCHE REFERENCE ELECTRODE WITH THE ANALYZER'S REFERENCE ELECTRODE HOUSING. THE INVESTIGATION DETERMINED THAT THE EVENT WAS CONSISTENT WITH THE CUSTOMER'S USE OF A THIRD-PARTY/NON-ROCHE REFERENCE ELECTRODE IN THE ANALYZER'S REFERENCE ELECTRODE HOUSING.