Roche 9180 Sodium electrode 03110419180Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04015630028702), received between Sep 14, 2018 and Feb 10, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 10, 2025Low Test Results; Low Test Results

  THE INITIAL REPORTER COMPLAINED OF DISCREPANT LOW RESULTS FOR 1 PATIENT SAMPLE TESTED FOR SODIUM (NA) ON A (B)(6) ELECTROLYTE ANALYZER. THE INITIAL RESULT WAS 109 MMOL/L WITH A DATA FLAG. THE CUSTOMER PERFORMED CLEANING AND CONDITIONING AND THE REPEAT RESULT WAS 138 MMOL/L. THE CUSTOMER REPEATED THE SAMPLE AND THE RESULT WAS AGAIN 109 MMOL/L. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE RESULT OF 138 MMOL/L WAS BELIEVED TO BE CORRECT BASED ON THE PATIENT¿S PREVIOUS RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21344710 ↗
• MalfunctionSep 14, 2018Low Test Results; Low Test Results

  THE CUSTOMER COMPLAINED OF DISCREPANT ISE INDIRECT NA FOR GEN.2 RESULTS FOR 1 PATIENT SAMPLE ON A ROCHE 9180 ELECTROLYTE ANALYZER COMPARED TO AN ELYTE INSTRUMENT. THE NA RESULT WAS 132 MMOL/L ON THE 9180 ELECTROLYTE ANALYZER. THE NA RESULT WAS 141 MMOL/L ON THE ELYTE INSTRUMENT. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. NO ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE CUSTOMER PERFORMED DAILY MAINTENANCE AND CALIBRATION. THE CUSTOMER REPEATED THE SAMPLE. THE REPEAT NA RESULT WAS 137 MMOL/L ON THE 9180 ELECTROLYTE ANALYZER AND 142 MMOL/L ON THE ELYTE INSTRUMENT. THE NA ELECTRODE LOT NUMBER AND EXPIRATION DATE WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7877768 ↗