ISE Standard High 11183982216Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04015630908684), received between Apr 17, 2023 and Apr 17, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Incorrect Measurement” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 17, 2023Incorrect Measurement; Insufficient Device Problem Information; Incorrect Measurement; Insufficient Device Problem Information

  THERE WAS AN ALLEGATION OF QUESTIONABLE GEN.2 ISE INDIRECT FOR NA AND CL RESULTS FOR 24 PATIENT SAMPLES ON A COBAS 8000 COBAS ISE MODULE. THE CUSTOMER PROVIDED AN EXAMPLE OF DISCREPANT RESULTS FOR 1 PATIENT SAMPLE. THE INITIAL NA RESULT WAS 150 MMOL/L AND THE INITIAL CL RESULT WAS 92 MMOL/L. THE INITIAL RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE CUSTOMER WAS PROMPTED TO REPEAT THE SAMPLE AS THEY STARTED RECEIVING VOLTAGE-LEVEL ERRORS AND HIGH RESULTS. THE SAMPLE WAS REPEATED AND THE NA RESULT WAS 140 MMOL/L AND THE CL RESULT WAS 104 MMOL/L. THE REPEAT RESULTS WERE DEEMED CORRECT. THE ELECTRODE LOTS AND EXPIRATION DATES WERE REQUESTED BUT NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16753551 ↗