Sodium electrodeRecalls & reported problems across all models

We found 3 models of Sodium electrode by Roche Diagnostics GmbH in the FDA's device registry (GUDID). Together they are named in 150 adverse event reports in the FDA's MAUDE database, received between Jul 13, 2018 and Sep 22, 2026 — classified as 150 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (67 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Sodium electrode problems

Sodium electrode models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Sodium electrode 10825468001

  ELECTRODE, ION SPECIFIC, SODIUM
  99 reports
• Sodium electrode 10825468001

  ELECTRODE, ION SPECIFIC, SODIUM
  26 reports
• Sodium Electrode 21029371001

  ELECTRODE, ION SPECIFIC, SODIUM
  25 reports

Recent Sodium electrode adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026High Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50852947 ↗
• MalfunctionSep 18, 2026Low Test Results

  There was an allegation of questionable ISE results from the cobas 6000 c 501 module. One example for Sodium was provided.The initial result was 116 mmol/L, and the doctor questioned the result and requested repeat testing.The repeat result using an Istat analyzer was 125 mmol/L.The repeat result was believed to be correct.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50820994 ↗
• MalfunctionSep 2, 2026Non Reproducible Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50563620 ↗
• MalfunctionAug 19, 2026High Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50327398 ↗
• MalfunctionApr 20, 2026High Test Results; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED A QUESTIONABLE SODIUM ELECTRODE ASSAY RESULT FOR ONE PATIENT'S SAMPLE TESTED ON THE COBAS 6000 C (501) MODULE. THE INITIAL RESULT FROM THE MODULE WAS 151 MMOL/L. THE REPEAT RESULT FROM ANOTHER C 501 MODULE WAS 139 MMOL/L. THE INITIAL RESULT DID NOT MATCH THE PATIENT'S HISTORY, PROMPTING THE RERUN. THE REPEAT RESULT WAS DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24930793 ↗
• MalfunctionApr 13, 2026Incorrect Measurement; Incorrect, Inadequate or Imprecise Result or Readings

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT SODIUM ELECTRODE RESULTS FOR ONE PATIENT SAMPLE TESTED ON A COBAS 6000 C (501) MODULE. A PHYSICIAN QUESTIONED THE INITIAL RESULT. THE CUSTOMER THEN RAN CONTROLS ON THE ANALYZER AND THESE WERE OUTSIDE OF RANGE LOW. THE SAMPLE WAS REPEATED ON A SECOND ANALYZER. THE SAMPLE INITIALLY RESULTED IN A SODIUM VALUE OF 128 MMOL/L AND IT REPEATED AS 134 MMOL/L. THE REPEAT VALUE WAS DEEMED CORRECT AND A CORRECTED REPORT WAS ISSUED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24858022 ↗
• MalfunctionMar 20, 2026High Test Results; Insufficient Device Problem Information

  WE RECEIVED AN ALLEGATION OF QUESTIONABLE SODIUM ELECTRODE RESULTS FOR 1 PATIENT SAMPLE TESTED ON A COBAS C 303 ANALYTICAL UNIT. THE INITIAL RESULT WAS 160 MMO/L. THE PHYSICIAN QUESTIONED THE INITIAL RESULT AS IT WAS HIGHER THAN THE PATIENT'S HISTORY AND MEDICAL CONDITION. THE SAMPLE WAS THEN REPEATED ON A DIFFERENT ANALYTICAL UNIT PER THE CUSTOMER'S ROUTINE PROCEDURES, AND THE REPEAT RESULT WAS 145 MMOL/L. THE LOWER RESULT WAS CONSISTENT WITH THE PATIENT'S HEALTH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24650528 ↗
• MalfunctionMar 18, 2026Incorrect Measurement; Incorrect, Inadequate or Imprecise Result or Readings

  THERE WAS AN ALLEGATION OF QUESTIONABLE SODIUM ELECTRODE (NA), POTASSIUM ELECTRODE (K), AND ISE INDIRECT NA-K-CL FOR GEN.2 (CL) RESULTS FOR 1 PATIENT SAMPLE ON A COBAS 6000 C (501) MODULE. THIS MEDWATCH WILL COVER SODIUM. REFER TO MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE POTASSIUM RESULTS AND MEDWATCH WITH A1 PATIENT IDENTIFIER(B)(6) FOR INFORMATION ON THE CHLORIDE RESULTS. THE INITIAL NA RESULT WAS 123 MMOL/L, THE INITIAL K RESULT WAS 3.42 MMOL/L, AND THE INITIAL CL RESULT WAS 116.9 MMOL/L. THE CUSTOMER QUESTIONED THE RESULTS AS THEY WERE ACCOMPANIED BY A NEGATIVE ION GAP WHICH PROMPTED THEM TO REPEAT THE RESULTS. THE REPEAT NA RESULT WAS 137 MMOL/L, THE REPEAT K RESULT WAS 4.21 MMOL/L, AND THE REPEAT CL RESULT WAS 102.5 MMOL/L. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE REPEAT RESULTS WERE DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24629411 ↗
• MalfunctionFeb 5, 2026Low Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE SODIUM ELECTRODE RESULTS FROM THE COBAS C 303 ANALYTICAL UNIT FOR TEN PATIENTS. RESULTS WERE PROVIDED FOR TWO PATIENTS. PATIENT 1'S INITIAL RESULT WAS 129.8 MMOL/L. THE REPEAT RESULT ON ANOTHER ANALYZER WAS 135 MMOL/L. PATIENT 2'S INITIAL RESULT WAS 133 MMOL/L. THE REPEAT RESULT ON ANOTHER ANALYZER WAS 140 MMOL/L. THE INITIAL RESULTS WERE QUESTIONED BY THE CUSTOMER WHEN THEY NOTICED THAT THERE WAS A DISCREPANCY IN THE SODIUM RESULTS BETWEEN THE TWO ANALYZERS. NO QUESTIONABLE RESULTS WERE RELEASED OUTSIDE OF THE LABORATORY. THE REPEAT RESULTS WERE DEEMED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24270474 ↗
• MalfunctionJan 7, 2026High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ISE INDIRECT NA-K-CL FOR GEN.2 (CL), POTASSIUM ELECTRODE (K), AND SODIUM ELECTRODE (NA) RESULTS FOR 5 PATIENT SAMPLES ON A COBAS 8000 COBAS ISE MODULE. THIS MEDWATCH WILL COVER NA. REFER TO MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE K RESULTS AND MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE CL RESULTS. THE CUSTOMER HAD NOTICED AN INCREASED FREQUENCY OF HIGH RESULTS WHICH PROMPTED THEM TO REPEAT PATIENT SAMPLES. FOR SAMPLE 1, THE INITIAL NA RESULT WAS 167 MMOL/L, THE INITIAL K RESULT WAS 5.2 MMOL/L, AND THE INITIAL CL RESULT WAS 123 MMOL/L. THE SAMPLE WAS REPEATED ON ANOTHER ANALYZER AND THE NA RESULT WAS 141 MMOL/L, THE K RESULT WAS 4.5 MMOL/L, AND THE CL RESULT WAS 108 MMOL/L. FOR SAMPLE 2, THE INITIAL NA RESULT WAS 244 MMOL/L AND THE INITIAL K RESULT WAS 7.8 MMOL/L. THE SAMPLE WAS REPEATED ON ANOTHER ANALYZER. THE NA RESULT WAS 140 MMOL/L AND THE K RESULT WAS 4.1 MMOL/L. FOR SAMPLE 3, THE INITIAL NA RESULT WAS 220 MMOL/L, THE INITIAL K RESULT WAS 8.4 MMOL/L, AND THE INITIAL CL RESULT WAS 166 MMOL/L. THE SAMPLE WAS REPEATED ON ANOTHER ANALYZER AND THE NA RESULT WAS 131 MMOL/L, THE K RESULT WAS 5.3

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23987894 ↗
• MalfunctionDec 30, 2025High Test Results; Insufficient Device Problem Information; Non Reproducible Results; High Test Results; Insufficient Device Problem Information; Non Reproducible Results

  THE INITIAL REPORTER QUESTIONED THE RESULTS FOR MULTIPLE PATIENT SAMPLES TESTED ON A COBAS PRO ISE ANALYTICAL UNIT. APPROXIMATELY 200 PATIENT SAMPLES WERE REPEATED, AND 70 CORRECTED REPORTS WERE ISSUED. DISCREPANT RESULTS WERE PROVIDED FOR 2 PATIENT SAMPLES TESTED FOR SODIUM ELECTRODE (NA). PATIENT 1 INITIAL RESULT WAS 140 MEQ/L. THE REPEAT RESULT WAS 132.6 MEQ/L. PATIENT 2 INITIAL RESULT WAS 141 MEQ/L. THE REPEAT RESULT WAS 134.3 MEQ/L. THE HIGH RESULTS WERE QUESTIONED, AND THE SAMPLES WERE REPEATED ON A DIFFERENT COBAS PRO ISE ANALYZER. THE REPEAT RESULTS WERE BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23920792 ↗
• MalfunctionDec 17, 2025Low Test Results; Low Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ISE INDIRECT NA-K-CL FOR GEN.2 RESULTS FOR 1 PATIENT SAMPLE ON A COBAS 6000 C (501) MODULE. THIS MEDWATCH WILL COVER SODIUM. REFER TO MEDWATCH WITH A1 PATIENT IDENTIFIER: (B)(6) FOR INFORMATION ON THE CHLORIDE RESULTS AND MEDWATCH WITH A1 PATIENT IDENTIFIER: (B)(6) FOR INFORMATION ON THE POTASSIUM RESULTS. THE INITIAL NA RESULT WAS 104 MMOL/L, THE INITIAL K RESULT WAS 3.5 MMOL/L, AND THE INITIAL CL RESULT WAS 73.2 MMOL/L. THE CUSTOMER QUESTIONED THE RESULTS WHICH PROMPTED THEM TO REPEAT THE SAMPLE. THE SAMPLE WAS REPEATED ON ANOTHER C 501 ANALYZER AND THE NA RESULT WAS 129 MMOL/L, THE K RESULT WAS 4.32 MMOL/L, AND THE CL RESULT WAS 94.3 MMOL/L. THE REPEAT RESULTS WERE DEEMED CORRECT. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23830577 ↗
• MalfunctionDec 5, 2025Low Test Results; Low Test Results

  THE INITIAL REPORTER STATED THEY HAVE BEEN HAVING ONGOING ISSUES WITH CALIBRATION FAILURES AND QUALITY CONTROL RECOVERY ON THE COBAS 8000 ISE MODULE. A PHYSICIAN QUESTIONED SODIUM ELECTRODE RESULTS FOR AN UNSPECIFIED NUMBER OF PATIENT SAMPLES. THE CUSTOMER PROVIDED AN EXAMPLE OF ONE PATIENT SAMPLE WITH DISCREPANT SODIUM RESULTS. THE SAMPLE INITIALLY RESULTED IN A SODIUM VALUE OF 122 MMOL/L. AFTER THE PHYSICIAN QUESTIONED THE RESULT, THE SAMPLE WAS REPEATED ON AN UNKNOWN ANALYZER, RESULTING IN A VALUE OF 134 MMOL/L. THE REPEAT VALUE WAS DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23729128 ↗
• MalfunctionDec 4, 2025Low Test Results; Low Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE SODIUM RESULTS FROM THE COBAS PRO ISE ANALYTICAL UNIT. THE SAMPLES WERE REPEATED ON ANOTHER COBAS PRO ISE ANALYZER WITH RESULTS IN THE NORMAL RANGE. SAMPLE 1 INITIAL RESULT WAS 132 MMOL/L, AND THE REPEAT RESULT WAS 138.4 MMOL/L. SAMPLE 2 INITIAL RESULT WAS 133 MMOL/L, AND THE REPEAT RESULT WAS 139.3 MMOL/L. SAMPLE 3 INITIAL RESULT WAS 131 MMOL/L, AND THE REPEAT RESULT WAS 137.8 MMOL/L. SAMPLE 4 INITIAL RESULT WAS 131 MMOL/L, AND THE REPEAT RESULT WAS 137.9 MMOL/L. SAMPLE 5 INITIAL RESULT WAS 125 MMOL/L, AND THE REPEAT RESULT WAS 131.8 MMOL/L. THE REPEAT RESULTS WERE BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23714997 ↗
• MalfunctionNov 3, 2025Low Test Results; Insufficient Device Problem Information; Low Test Results; Insufficient Device Problem Information

  THERE WAS AN ALLEGATION OF QUESTIONABLE SODIUM ELECTRODE RESULTS FOR 1 PATIENT SAMPLE ON A COBAS 8000 ISE 1800 MODULE. THE INITIAL RESULT WAS 120.7 MMOL/L. THE SAMPLE WAS REPEATED ON ANOTHER MODULE, AND THE RESULT WAS 136 MMOL/L. THIS RESULT WAS BELIEVED TO BE CORRECT. A DELTA CHECK IN THE CUSTOMER'S SYSTEM PROMPTED THE SAMPLE TO BE REPEATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23453684 ↗

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