ISE Sodium Electrode 4838084001Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04015630036189), received between Dec 19, 2022 and Apr 30, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (3 reports).

3 other recalls cover devices cleared under the same FDA submission (K071211); they may or may not involve this specific model.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 30, 2024Low Test Results; Low Test Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ISE INDIRECT NA FOR GEN.2 RESULTS FROM AN UNSPECIFIED NUMBER OF PATIENT SAMPLES TESTED ON THE COBAS C 111 WITH ISE. THE REPORTER STATED THEY HAVE BEEN RECEIVING LOW NA PATIENT RESULTS FROM THE ANALYZER. THE REPORTER WAS ABLE TO PROVIDE ONE PATIENT SAMPLE WITH DISCREPANT RESULTS: IT IS UNCLEAR IF THE INITIAL RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE INITIAL RESULT DID NOT MATCH THE DELTA CHECK PROMPTING THE RERUN OF THE PATIENT SAMPLE. THE INITIAL NA RESULT FROM THE ANALYZER WAS 129 MMOL/L. THE FIRST REPEAT RESULT FROM THE SIEMENS DIMENSION ANALYZER WAS 140 MMOL/L. THE SECOND REPEAT RESULT FROM THE ANALYZER WAS 140 MMOL/L. THE REPEAT RESULT WAS DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19212671 ↗
• MalfunctionOct 24, 2023Low Test Results; Low Test Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 9 PATIENTS' SAMPLES TESTED WITH ISE SODIUM (NA) ASSAY ON A COBAS C111 SYSTEM WHEN COMPARED TO A COBAS 600 C501 ANALYZER. SAMPLE 1 (PATIENT 1): 125.3 MMOL/L. RERUN RESULT: 137 MMOL/L (TESTED ON A DIFFERENT ANALYZER). SAMPLE 2 (PATIENT 2): 126.2 MMOL/L. RERUN RESULT: 140 MMOL/L (TESTED ON A DIFFERENT ANALYZER). SAMPLE 3 (PATIENT 3): 128.1 MMOL/L. RERUN RESULT: 135 MMOL/L (TESTED ON A DIFFERENT ANALYZER). SAMPLE 4 (PATIENT 4): 144.3 MMOL/L. RERUN RESULT: 158 MMOL/L (TESTED ON A DIFFERENT ANALYZER). SAMPLE 5 (PATIENT 5): 132.1 MMOL/L. RERUN RESULT: 139 MMOL/L (TESTED ON A DIFFERENT ANALYZER). SAMPLE 6 (PATIENT 6): 124.7 MMOL/L. RERUN RESULT: 132 MMOL/L (TESTED ON A DIFFERENT ANALYZER). SAMPLE 7 (PATIENT 7): 127.8 MMOL/L. RERUN RESULT: 144 MMOL/L (TESTED ON A DIFFERENT ANALYZER). SAMPLE 8 (PATIENT 8): 125.6 MMOL/L. RERUN RESULT: 136 MMOL/L (TESTED ON A DIFFERENT ANALYZER). SAMPLE 9 (PATIENT 9): 128.9 MMOL/L. RERUN RESULT: 136 MMOL/L (TESTED ON A DIFFERENT ANALYZER). THE PHYSICIAN QUESTIONED THE RESULTS AND ASKED FOR THE SAMPLES TO BE RERUN. THE REPEAT RESULTS WERE DEEMED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17994260 ↗
• MalfunctionDec 19, 2022Low Test Results; Low Test Results

    THE INITIAL REPORTER RECEIVED QUESTIONABLE ISE INDIRECT NA, K AND CI FOR GEN.2 RESULTS FOR ONE PATIENT SAMPLE TESTED ON THE COBAS C 111 WITH ISE. THE INITIAL RESULT WAS ACCIDENTALLY REPORTED OUTSIDE OF THE LABORATORY AND VERBALLY PROVIDED TO THE DOCTOR. THE DOCTOR STATED THAT THEY DID NOT TRUST THE RESULTS AND BECAUSE IT WAS LATE, THE DOCTOR SENT THE PATIENT TO THE EMERGENCY ROOM (ER) AND ANOTHER SAMPLE WAS COLLECTED FROM THE PATIENT. THE PATIENT SAMPLE WAS INITIALLY RUN ON (B)(6) 2022. THE REPORTER CALIBRATED AND RERAN THE PATIENT SAMPLE ON (B)(6) 2022. THE PATIENT SAMPLE WAS AGAIN RERUN ON (B)(6) 2022. THE REPEAT RESULTS OF THE INITIAL SAMPLE FROM (B)(6) 2022 WERE DEEMED CORRECT. THE CHLORIDE ELECTRODE LOT NUMBER IS 21523347 WITH AN EXPIRATION DATE OF 03-FEB-2023. THE POTASSIUM ELECTRODE LOT NUMBER IS 21521247 WITH AN EXPIRATION DATE OF 23-SEP-2022. THE SODIUM ELECTRODE LOT NUMBER AND THE EXPIRATION DATE WERE REQUESTED BUT NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16004634 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K071211. One submission often covers many models, so check the product and lot details in each record.

• Z-0387-2017 · Sep 27, 2016 · Terminated
  Roche COBAS INTEGRA c111 Analyzer, Chemistry (Photometric, Discrete), for clinical use Product Usage: The Roche COBAS INTEGRA c111 analyzer is an in-vitro diagnostic analyzer capa
• Z-0311-2012 · Oct 18, 2011 · Terminated
  Roche Cobas c 111 Analyzer The Roche Cobas c 111 analyzer is an in-vitro diagnostic analyzer capable of performing clinical chemistry, specific protein and electrolyte tests. Analy
• Z-1009-2009 · Nov 17, 2008 · Terminated
  Roche COBAS c 111 Analyzer with ISE module option, GMMI No. 04777433001; Roche Diagnostics, Indianapolis, IN. Is an in-vitro diagnostic analyzer capable of performing clinical che