cobas b 123 Sensor Cartridge BG/ISE/GLU/LAC 05170478001Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04015630037681), received between Mar 22, 2024 and Mar 22, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Non Reproducible Results” (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.

• MalfunctionMar 22, 2024Non Reproducible Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE GEN.2 ISE INDIRECT FOR NA AND K RESULTS FOR 1 PATIENT SAMPLE ON A COBAS 6000 C (501) MODULE. THIS MEDWATCH WILL COVER K. REFER TO MEDWATCH WITH A1 PATIENT IDENTIFIER PT (B)(6) FOR INFORMATION ON THE NA RESULTS. THE INITIAL NA RESULT WAS 126 MMOL/L AND THE INITIAL K RESULT WAS 4.66 MMOL/L. THE CUSTOMER QUESTIONED THE LOW RESULTS AND WAS PROMPTED TO REPEAT THE SAMPLE. THE SAMPLE WAS REPEATED ON ANOTHER (B)(6) ANALYZER AND THE REPEAT NA RESULT WAS 138 MMOL/L AND THE REPEAT K RESULT WAS 4.21 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 18960455 ↗