Potassium Electrode 3111628180Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04015630014293), received between Aug 22, 2018 and Aug 6, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (3 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 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 6, 2025Incorrect, Inadequate or Imprecise Result or Readings; Non Reproducible Results; Incorrect, Inadequate or Imprecise Result or Readings; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE POTASSIUM RESULTS FROM THE COBAS B 221 4 ROCHE OMNI S4 SYSTEM. THE SAMPLES WERE REPEATED AFTER THE CUSTOMER CLEANED THE ANALYZER. PATIENT 1 INITIAL RESULT WAS 10.84 MMOL/L, AND THE REPEAT RESULT WAS 4.63 MMOL/L. PATIENT 2 INITIAL RESULT WAS 6.82 MMOL/L, AND THE REPEAT RESULT WAS 3.8 MMOL/L. THE QUESTIONABLE RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22726604 ↗
• MalfunctionJun 13, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 2 PATIENTS' SAMPLES TESTED FOR POTASSIUM (K) ON A COBAS B221 6 ROCHE OMNI S6 SYSTEM. PATIENT 1 AND PATIENT 2 WERE INITIALLY TESTED (TUBE 1) WITH AN ARTERIAL BLOOD GAS (ABG) TEST ON A COBAS B221, WHILE SIMULTANEOUSLY, VENOUS BLOOD SAMPLES (TUBE 2) WERE DRAWN FROM PATIENT 1 AND PATIENT 2 AND TESTED ON DIFFERENT ANALYZERS. PATIENT 1: TUBE 1 RESULT: 2.61 MMOL/L. TUBE 2 RESULT: 4.2 MMOL/L (TESTED ON A BECKMAN COULTER AU5800 INSTRUMENT). PATIENT 2 WAS TESTED ON (B)(6) 2025: TUBE 1 RESULT: 3.74 MMOL/L. TUBE 2 RESULT: 4.7 MMOL/L (TESTED ON A C503 ANALYZER).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22206167 ↗
• MalfunctionMar 6, 2023Low Test Results; Low Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED A QUESTIONABLE RESULT FOR ONE PATIENT SAMPLE TESTED WITH THE POTASSIUM ELECTRODE ON A COBAS B 221 ANALYZER (SERIAL NUMBER (B)(4). THE WHOLE BLOOD SAMPLE WAS TESTED ON THE COBAS B 221 ANALYZER, RESULTING IN A POTASSIUM VALUE OF 2.85 MMOL/L.THE A SERUM SAMPLE COLLECTED AT THE SAME TIME AS THE COMPLAINED SAMPLE WAS TESTED ON A COBAS C 501 ANALYZER, RESULTING IN A POTASSIUM VALUE OF 4.1 MEQ/L. THE SERUM SAMPLE WAS REPEATED AGAIN ON THE C 501 ANALYZER ON (B)(6) 2023, RESULTING IN A VALUE OF 3.9 MMOL/L. THE RESULT WAS CORRECTED AFTER REPEAT TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16489549 ↗
• MalfunctionJan 18, 2023High Test Results; High Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR TWO PATIENT SAMPLES TESTED WITH THE POTASSIUM (K) AND SODIUM (NA) ELECTRODES ON A COBAS B 221 <6> SYSTEM. PATIENT SAMPLE 1: THE SAMPLE INITIALLY RESULTED IN A K VALUE OF 7.81 MMOL/L AND REPEATED AS 3.4 MMOL/L ON A SECOND COBAS B 221 SYSTEM. PATIENT SAMPLE 2: THE SAMPLE INITIALLY RESULTED IN A NA VALUE OF 124.8 MMOL/L AND REPEATED AS 135.6 MMOL/L ON A SECOND COBAS B 221 SYSTEM. THE SAMPLE INITIALLY RESULTED IN A K VALUE OF 16.74 MMOL/L AND REPEATED AS 5.38 MMOL/L ON A SECOND COBAS B 221 SYSTEM. THE REPEAT RESULTS WERE DEEMED CORRECT. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE K ELECTRODE LOT NUMBER WAS 21512951 WITH AN EXPIRATION DATE OF 21-JAN-2022. THE NA ELECTRODE LOT NUMBER AND EXPIRATION DATE WERE REQUESTED BUT NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16199621 ↗
• MalfunctionJan 19, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR TWO SAMPLES FROM THE SAME PATIENT TESTED WITH THE ROCHE OMNI ELECTRODE POTASSIUM ON A COBAS B 221 ROCHE OMNI S6 SYSTEM. THE SAMPLE VALUES WERE REPORTED OUTSIDE OF THE LABORATORY AND QUESTIONED BY A PHYSICIAN AS THE AVAILABLE OUTPUTS FROM PATIENT MONITORING DID NOT SUGGEST THAT THE PATIENT WAS HYPOKALEMIC. THE REPORTER ALSO MENTIONED THEY HAVE BEEN GETTING "SODIUM SIGNAL SENSOR UNSTABLE" ERRORS ON THE COBAS B 221 ANALYZER FOR SEVERAL MONTHS. THE REPORTER STATED THAT THE K ELECTRODE WAS LAST CHANGED ON THIS ANALYZER ON (B)(6) 2021. PER PRODUCT LABELING, THE K ELECTRODE IS STABLE FOR 26 WEEKS. THE FIRST SAMPLE FROM THE PATIENT RESULTED IN A K VALUE OF 3.14 MMOL/L WHEN TESTED ON THE COBAS B 221. THE SECOND SAMPLE FROM THE PATIENT RESULTED IN A K VALUE OF 3.14 MMOL/L WHEN TESTED ON THE COBAS B 221. A THIRD SAMPLE WAS COLLECTED FROM THE PATIENT AND TESTED ON A COBAS 6000 C (501) MODULE, RESULTING IN A K VALUE OF 4.2 MMOL/L. THIS VALUE WAS DEEMED CORRECT BY THE PHYSICIAN AS IT WAS CONSISTENT WITH THE CLINICAL PRESENTATION OF THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13290645 ↗
• MalfunctionAug 22, 2018Non Reproducible Results; Non Reproducible Results

  THE CUSTOMER QUESTIONED RESULTS FOR 3 PATIENTS TESTED FOR POTASSIUM (K) ON A COBAS B 221 SYSTEM. BASED ON THE DATA PROVIDED, THE RESULTS FOR 1 PATIENT ARE A REPORTABLE MALFUNCTION. THE INITIAL RESULT AT 5:59 A.M. WAS 6.34 MMOL/L. THE SAME SAMPLE WAS REPEATED AT 6:08 A.M. AND THE RESULT WAS 7.21 MMOL/L. THESE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY BUT THE PHYSICIAN DISMISSED THEM AND NO CLINICAL DECISIONS WERE MADE. THERE WAS NO ALLEGATION THAT AN ADVERSE EVENT OCCURRED. THE B 221 INSTRUMENT SERIAL NUMBER WAS (B)(4). THE K ELECTRODE WAS REQUESTED FOR INVESTIGATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7804341 ↗