Potassium Electrode 21029355001Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04015630918737), received between Nov 16, 2023 and Feb 20, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “High 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. How this data works · Data updated Oct 13, 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 20, 2024High Test Results; High Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH THE POTASSIUM ELECTRODE ON A COBAS INTEGRA 400 PLUS. THE SAMPLE INITIALLY RESULTED IN A POTASSIUM VALUE OF 7.4 MMOL/L, WITH A DATA FLAG INDICATING THE ISE WAS UNSTABLE. THE SAMPLE WAS AUTOMATICALLY REPEATED, RESULTING IN A POTASSIUM VALUE OF 8.5 MMOL/L WITH A DATA FLAG. THE CUSTOMER RE-CALIBRATED THE ISE TESTS, BUT CALIBRATION FAILED FOR POTASSIUM. THE CUSTOMER TRIED REPLACING THE ISE MIX TOWER, PRIMED THE ISE CALIBRATORS, AND ACTIVATED THE ELECTRODES, BUT THE POTASSIUM CALIBRATION STILL FAILED. DUE TO THE CALIBRATION FAILURE, THE SAMPLE WAS REPEATED AT ANOTHER LABORATORY. THE PATIENT SAMPLE WAS SENT TO ANOTHER LABORATORY FOR TESTING ON AN UNKNOWN ANALYZER, RESULTING IN A POTASSIUM VALUE OF 4.4 MMOL/L. THE REPEAT VALUE WAS DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18738232 ↗
• MalfunctionNov 16, 2023High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF ISE NOISE ALARMS AND QUESTIONABLE ISE INDIRECT GEN 2 POTASSIUM RESULTS FROM THE COBAS PRO ISE ANALYTICAL UNIT. ONE EXAMPLE WAS PROVIDED OF AN INITIAL RESULT WAS 7.16 MMOL/L AND A REPEAT RESULT OF 4.27 MMOL/L. THE QUESTIONABLE RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THE REPEAT RESULT WAS BELIEVED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18153889 ↗