Potassium Electrode 10825441001 (UDI 08430215011539)Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 08430215011539), received between Sep 19, 2018 and Jul 23, 2024 — classified as 14 malfunctions.

The most frequently reported specific device problem is “High Test Results” (8 reports).

10 other recalls cover devices cleared under the same FDA submission (K060373); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 23, 2024High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  WE RECEIVED AN ALLEGATION OF QUESTIONABLE ISE RESULTS FOR 1 PATIENT PLASMA SAMPLE TESTED ON A COBAS C303 ANALYTICAL UNIT. RESULTS FOR THE POTASSIUM (K) TEST WERE AFFECTED. INITIAL RESULT: 6.06 MMOL/L. THE PHYSICIAN QUESTIONED THE INITIAL RESULT. THE PATIENT WENT TO THE ER FOR THE NEW SAMPLE COLLECTION WHICH RESULTED IN A K VALUE OF 3.9 MMOL/L. THE CUSTOMER THEN REPEATED THE ORIGINAL SAMPLE ON THE SAME ANALYZER AND THE REPEAT RESULT WAS 4.30 MMOL/L. THE REPEAT RESULT WAS DEEMED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19810802 ↗
• MalfunctionJun 11, 2024Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR TWO PATIENT SAMPLES TESTED ON A COBAS C 303 ANALYTICAL UNIT. SAMPLE 1 HAD DISCREPANT RESULTS WHEN TESTED WITH THE NA ELECTRODE AND CL ELECTRODE. REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE NA ELECTRODE AND REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE CL ELECTRODE. SAMPLE 1 ALSO HAD DISCREPANT RESULTS WHEN TESTED WITH THE ELECSYS TROPONIN T GEN 5 ON A COBAS PURE E 402 ANALYTICAL UNIT. REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE TROPONIN T ASSAY. SAMPLE 2 HAD DISCREPANT RESULTS WHEN TESTED WITH THE NA ELECTRODE, K ELECTRODE, CL ELECTRODE, AND CALCIUM GEN.2. THIS MEDWATCH WILL APPLY TO THE K ELECTRODE. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE NA ELECTRODE. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE CL ELECTRODE. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE CALCIUM ASSAY. A PHYSICIAN QUESTIONED THE INITIAL SAMPLE VALUES SO THE SAMPLES WERE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19511488 ↗
• MalfunctionMay 29, 2024Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  WE RECEIVED AN ALLEGATION OF QUESTIONABLE ISE RESULTS FOR 1 PATIENT SERUM SAMPLE TESTED ON A COBAS PRO ISE ANALYTICAL UNIT WHEN COMPARED TO A DIFFERENT COBAS PRO ISE ANALYTICAL UNIT. RESULTS FOR THE POTASSIUM (K) TEST WERE AFFECTED. INITIAL RESULT: 1.8 MMOL/L. THE CUSTOMER QUESTIONED THE INITIAL RESULT. NO QUESTIONABLE RESULT WAS REPORTED OUTSIDE THE LABORATORY AND THE SAMPLE WAS REPEATED. REPEAT RESULT: 3.8 MMOL/L (TESTED ON ANOTHER COBAS PRO). THE REPEAT RESULT WAS DEEMED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19415080 ↗
• MalfunctionMar 29, 2024High Test Results; High Test Results

  THE INITIAL REPORTER COMPLAINED OF A DISCREPANT HIGH RESULT FOR 1 PATIENT SAMPLE TESTED FOR K ELECTRODE (K) ON A COBAS 6000 C (501) MODULE. THE INITIAL RESULT WAS 6.11 MMOL/L. THE CUSTOMER NOTED THE SAMPLE WAS CLOTTED. OTHER RESULTS FOR THIS SAMPLE WERE ACCOMPANIED BY DATA FLAGS. THE CUSTOMER REMOVED THE CLOT AND REPEATED THE SAMPLE WITH A RESULT OF 4.68 MMOL/L. THIS RESULT WAS BELIEVED TO BE CORRECT. THE QUESTIONABLE RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19005955 ↗
• MalfunctionOct 20, 2023High Test Results; High Test Results

  THE WAS AN ALLEGATION OF A QUESTIONABLE ISE INDIRECT GEN 2 POTASSIUM RESULT FROM THE COBAS 8000 COBAS ISE MODULE. ANOTHER CUSTOMER SITE HAD ISSUES WITH QUESTIONABLE POTASSIUM RESULTS FOR ONE PATIENT. THE RESULT FROM A SIEMENS ANALYZER WAS 4.0 MMOL/L. AN ALIQUOT OF THE SAMPLE WAS TESTED ON ONE OF THE COBAS 8000 COBAS ISE MODULES AT THAT CUSTOMER'S SITE AND THE RESULTS WERE 4.0 MMOL/L AND 6.4 MMOL/L. THE CUSTOMER THEN TESTED THE SAMPLE ON ALL FOUR COBAS MODULES AND THE RESULTS WERE BETWEEN 6.4 - 6.5 MMOL/L WITH A DATA FLAG. THE SAMPLE WAS THEN TESTED AT THIS LABORATORY ON THE COBAS 8000 COBAS ISE MODULE AND THE RESULT WAS 5.0 MMOL/L. THE RESULT FROM THIS ANALYZER WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THE RESULT FROM A SIEMENS ANALYZER OF 4.0 MMOL/L WAS BELIEVED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17977441 ↗
• MalfunctionOct 19, 2023High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THE WAS AN ALLEGATION OF QUESTIONABLE ISE INDIRECT GEN 2 POTASSIUM RESULTS FROM COBAS 8000 COBAS ISE MODULES. AT 0800, THE RESULT FOR THE PATIENT WAS 6.7 MMOL/L WITH A DATA FLAG. THE SAMPLE WAS TESTED ON TWO OTHER COBAS ANALYZERS AND THE RESULT WAS THE SAME THE RESULT WAS REPORTED OUTSIDE OF THE LABORATORY TO THE DOCTOR WHO HAD THE PATIENT GO TO THE HOSPITAL ER. THE RESULT FROM A NEW SAMPLE USING A SIEMENS ANALYZER WAS 4.0 MMOL/L. ON (B)(6) 2023, THE FIRST SAMPLE WAS RETESTED ON THREE COBAS ISE UNITS IN THE LABORATORY. ALL RESULTS WERE 6.7 MMOL/L. THE SAMPLE WAS SENT TO TWO REFERENCE LABORATORIES AND THE RESULTS WERE 7.0 AND 6.5 MMOL/L. AN ALIQUOT OF THE SECOND SAMPLE DRAWN AT THE ER WAS TESTED ON THE COBAS AND THE RESULTS WERE 4.0 MMOL/L AND 6.4 MMOL/L. THE CUSTOMER THEN TESTED THE SAMPLE ON ALL FOUR COBAS MODULES AND THE RESULTS WERE BETWEEN 6.4 - 6.5 MMOL/L WITH A DATA FLAG. THE SAMPLE WAS TESTED AT A DIFFERENT REFERENCE LABORATORY AND THE RESULT WAS 5.0 MMOL/L. THE RESULTS OBTAINED AT THE HOSPITAL ER WERE BELIEVED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17969665 ↗
• MalfunctionAug 16, 2023Unable to Obtain Readings; Unable to Obtain Readings

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR FOUR PATIENT SAMPLES TESTED WITH THE K ELECTRODE ON A COBAS 6000 C (501) MODULE. AN EXPERIENCED USER IN THE LABORATORY NOTICED THE SAMPLES HAD CRITICAL VALUES AND QUICKLY REPEATED TESTING ON A SECOND ANALYZER. THE REPEAT RESULTS FROM THE SECOND ANALYZER WERE DEEMED CORRECT AND NURSES WERE NOTIFIED OF THE CHANGES IN RESULTS. THE FIRST SAMPLE INITIALLY RESULTED IN A K VALUE OF 3.73 MMOL/L AND IT REPEATED AS 5.03 MMOL/L. THE SECOND SAMPLE INITIALLY RESULTED IN A K VALUE OF 3.04 MMOL/L AND IT REPEATED AS 4.19 MMOL/L. THE THIRD SAMPLE INITIALLY RESULTED IN A K VALUE OF 3.87 MMOL/L AND IT REPEATED AS 5.22 MMOL/L. THE FOURTH SAMPLE INITIALLY RESULTED IN A K VALUE OF 3.06 MMOL/L AND IT REPEATED AS 4.07 MMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17560563 ↗
• MalfunctionJul 20, 2023Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER ALLEGED NON-REPRODUCIBLE POTASSIUM RESULTS FOR ONE PATIENT'S SAMPLES TESTED WITH THE K ELECTRODE ON COBAS 8000 ISE 900 MODULE USING LITHIUM HEPARINIZED TUBES WHEN COMPARED TO RESULTS OBTAINED IN THE HOSPITAL USING DRY TUBES. THE FOLLOWING RESULTS WERE OBTAINED: LABORATORY, HEPARINIZED TUBE: 2.3 MMOL/L AND 2.4 MMOL/L HOSPITAL, DRY TUBE: 3.3 MMOL/L AND 3.5 MMOL/L THE CUSTOMER RAN A COMPARISON BETWEEN HEPARINIZED TUBES AND DRY TUBES FROM THE SAME PATIENT WITH THE FOLLOWING RESULTS: 1ST SAMPLE, DRY TUBE: 3.9 AND 4.0 MMOL/L 2ND SAMPLE, HEPARINIZED TUBE: 3.7 AND 3.7 MMOL/L 3RD FILE, HEPARINIZED TUBE: 3.3 AND 3.4 MMOL/L THE PATIENT RETURNED ON (B)(6) 2023 AND WAS MEASURED WITH HEPARINIZED TUBES RESULTING IN VALUES OF 5.2 MMOL/L AND 5.0 MMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17362998 ↗
• MalfunctionDec 20, 2022Incorrect Measurement; Incorrect Measurement

  THERE WAS AN ALLEGATION OF A QUESTIONABLE ISE INDIRECT GEN 2 POTASSIUM RESULT FROM THE COBAS 4000 C (311) ANALYZER. THE INITIAL RESULT WAS 5.48 MMOL/L AND WAS REPORTED OUTSIDE OF THE LABORATORY. THE DOCTOR QUESTIONED THE RESULT AND THE REPEAT RESULT WAS 4.19 MMOL/L. A NEW SAMPLE WAS DRAWN FROM THE PATIENT AND THE RESULT MATCHED THE REPEAT RESULT. NO SPECIFIC DATA WAS PROVIDED. THE ELECTRODE LOT NUMBER WAS J46 WITH AN EXPIRATION DATE OF 24-MAY-2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16016575 ↗
• MalfunctionNov 22, 2022High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE GEN.2 ISE INDIRECT FOR K RESULTS FOR 1 PATIENT SAMPLE ON A COBAS 8000 COBAS ISE MODULE. ON (B)(6) 2022, TWO SAMPLES WERE COLLECTED FROM THE PATIENT AT THE SAME TIME. ON (B)(6) 2022, THE INITIAL K RESULT FROM THE FIRST SAMPLE WAS 5.9 MMOL/L. THE SAMPLE WAS REPEATED TWO MORE TIMES AND THE RESULT BOTH TIMES WAS 6.0 MMOL/L. THE RESULT OF 6.0 MMOL/L WAS REPORTED OUTSIDE OF THE LABORATORY. ON (B)(6) 2022, THE SECOND SAMPLE WAS REPEATED AND THE K RESULT WAS 5.2 MMOL/L. THE REPEAT RESULT OF 5.2 MMOL/L WAS DEEMED CORRECT. THE K ELECTRODE LOT NUMBER IS J8377. THE EXPIRATION DATE WAS REQUESTED BUT NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15846263 ↗
• MalfunctionOct 13, 2022High Test Results; High Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR TWO PATIENT SAMPLES, TESTED WITH ISE INDIRECT K FOR GEN. 2 ON A COBAS 8000 ISE 1800 MODULE. PATIENT 1: ON (B)(6) 2022, THE PATIENT SAMPLE WAS INITIALLY MEASURED ON A VISTA ANALYZER IN A DIFFERENT HOSPITAL, RESULTING IN A K VALUE OF 5.4 MMOL/L. AN ALIQUOT FROM THIS BLOOD DRAWING WAS PROVIDED TO THE CUSTOMER'S LABORATORY AND RE-MEASURED ON TWO DIFFERENT INSTRUMENT LINES. THIS MEDWATCH WILL COVER LINE 1 OF THE INSTRUMENT (1990-01). REFER TO MEDWATCH WITH A1 PATIENT IDENTIFIER: (B)(6) FOR LINE 2 OF THE INSTRUMENT (1990-02). ON (B)(6) 2022, THE ALIQUOT OF THE SAMPLE WAS RUN ON LINE 1, ISE 1 MODULE, RESULTING IN A K VALUE OF 6.0 MMOL/L. AFTER RE-CALIBRATION, THE SAMPLE WAS REPEATED ON LINE 1, ISE 1 MODULE, AND ISE 2 MODULE, RESULTING IN K VALUES OF 5.7 MMOL/L AND 5.9 MMOL/L. THE INITIAL RESULT OBTAINED ON THE VISTA ANALYZER WAS DEEMED CORRECT. NO QUESTIONABLE RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. REFER TO THE ATTACHED DATA "PT-74745_PT-74746" FOR ADDITIONAL RESULTS OBTAINED ON THE DIFFERENT BLOOD DRAWS IN THE HOSPITAL AND THE RESPECTIVE ALIQUOTS IN THE CUSTOMER'S LABORATORY. DURING TROUBLESHOOTING IN THE CUSTOMER'S

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15600690 ↗
• MalfunctionOct 13, 2022High Test Results; High Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR TWO PATIENT SAMPLES, TESTED WITH ISE INDIRECT K FOR GEN. 2 ON A COBAS 8000 ISE 1800 MODULE. PATIENT 1: ON (B)(6) 2022, THE PATIENT SAMPLE WAS INITIALLY MEASURED ON A VISTA ANALYZER IN A DIFFERENT HOSPITAL, RESULTING IN A K VALUE OF 5.4 MMOL/L. AN ALIQUOT FROM THIS BLOOD DRAWING WAS PROVIDED TO THE CUSTOMER'S LABORATORY AND RE-MEASURED ON TWO DIFFERENT INSTRUMENT LINES. THIS MEDWATCH WILL COVER LINE 2 OF THE INSTRUMENT (B)(4). REFER TO MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR LINE 1 OF THE INSTRUMENT (B)(4). ON (B)(6) 2022, THE ALIQUOT OF THE SAMPLE WAS RUN ON LINE 2, ISE 3 AND ISE 4 MODULE, RESULTING IN A K VALUE OF 5.8 MMOL/L AND 5.9 MMOL/L. AFTER RE-CALIBRATION, THE SAMPLE WAS REPEATED ON LINE 2, ISE 3 MODULE, AND ISE 4 MODULE, RESULTING IN K VALUES OF 5.8 MMOL/L AND 5.8 MMOL/L. THE INITIAL RESULT OBTAINED ON THE VISTA ANALYZER WAS DEEMED CORRECT. NO QUESTIONABLE RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. DURING TROUBLESHOOTING IN THE CUSTOMER'S LABORATORY, A SECOND SAMPLE FROM A DIFFERENT PATIENT GENERATED DIFFERENT RESULTS WHEN COMPARING THE K VALUES OBTAINED ON INSTRUMENT LINE 1 AND 2. PATIENT 2: ON (B)(6)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15600634 ↗
• MalfunctionNov 15, 2018High Test Results; High Test Results

  THE CUSTOMER RECEIVED QUESTIONABLE HIGH ISE INDIRECT GEN.2 POTASSIUM RESULTS FOR PATIENT SAMPLE FROM THE COBAS 6000 C501 MODULE SERIAL NUMBER (B)(4). THE CUSTOMER SUSPECTED AN INTERFERENCE WITH THE LITHIUM HEPARIN SAMPLES. THE INITIAL RESULT FROM A LITHIUM HEPARIN SAMPLE WAS 8.08 MMOL/L AND WAS REPORTED OUTSIDE OF THE LABORATORY TO THE DOCTOR. THE PATIENT WAS MOVED TO INTENSIVE CARE. A NEW (CITRATED PLASMA) SAMPLE WAS DRAWN AND THE POTASSIUM RESULT WAS 4.80 MMOL/L. A THIRD (LITHIUM HEPARIN) SAMPLE WAS DRAWN AND THE RESULT WAS >10.0 MMOL/L WITH A DATA FLAG. THIS SAMPLE WAS THEN TESTED ON A BGA (ABL 90 FLEX) AND THE RESULT WAS 9.6 MMOL/L. A FOURTH (CITRATED PLASMA) SAMPLE WAS DRAWN AND THE RESULT WAS 3.7 MMOL/L ON THE COBAS C501 ANALYZER AND THE RESULT WAS 3.7 MMOL/L ON THE ABL 90 FLEX ANALYZER. ON (B)(6) 2018, A FIFTH (LITHIUM HEPARIN) SAMPLE WAS DRAWN AND THE RESULT WAS 4.15 MMOL/L. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8074136 ↗
• MalfunctionSep 19, 2018Non Reproducible Results; Non Reproducible Results

  THE CUSTOMER STATED THAT THEY RECEIVED AN ERRONEOUS RESULT FOR ONE PATIENT SAMPLE TESTED FOR ISE INDIRECT K FOR GEN.2 ON A COBAS 6000 C (501) MODULE. THE CUSTOMER ALSO COMPLAINED OF A DIFFERENCE IN THE SERUM INDEX VALUES OF THE SAMPLE WHEN REPEATED. THE COMPLAINED SAMPLE IS LIPEMIC. THE SAMPLE INITIALLY RESULTED WITH A K VALUE OF 5.50 MMOL/L AND THIS VALUE WAS REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE WAS REPEATED, RESULTING WITH A K VALUE OF 3.99 MMOL/L. NO ADVERSE EVENTS WERE ALLEGED TO HAVE OCCURRED WITH THE PATIENT. THE K ELECTRODE LOT NUMBER AND EXPIRATION DATE WERE ASKED FOR, BUT NOT PROVIDED. CALIBRATION AND CONTROLS ARE WITHIN SPECIFICATIONS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7888820 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K060373. One submission often covers many models, so check the product and lot details in each record.

• Z-2476-2019 · Jul 18, 2019 · Terminated
  cobas e 601 module (cobas 6000 Modular Series system) Part Number: 04745922001
• Z-1268-2018 · Dec 18, 2017 · Terminated
  c6000, Chemistry (Photometric, Discrete), for clinical use. - cobas e 601 module: Immunoassay Analyzer, Catalog Numbers: 04745922001, 05036348001, 05860652001, 04745922692, 0503634
• Z-0909-2018 · Jul 18, 2017 · Terminated
  cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL +
• Z-0378-2018 · Jun 29, 2017 · Terminated
  Brand Name: cobas c 6000 MODULAR Series System e 601 cobas c 8000 MODULAR Series System - e 602 Roche / Hitachi MODULAR Analytics Combination System Model/Catalog/Part Number
• Z-2049-2017 · Mar 21, 2017 · Terminated
  Sample probes associated with: cobas 6000 Series System, cobas 8000 Modular Analyzer Series, cobas c 311 analyzer cobas c 501/502 cobas c 701/702 cobas 8000 ISE Product Usage: Th
• Z-0096-2017 · Jul 15, 2016 · Terminated
  cobas 6000 Series system c6000, Chemistry (Photometric, Discrete), for clinical Use. Modular e601: Immunoassay Analyzer Product Usage: The cobas p501/p701 instrument stores primar
• Z-1791-2014 · May 21, 2014 · Terminated
  cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay
• Z-1792-2014 · May 21, 2014 · Terminated
  cobas 8000 analyzer series Operators Manual Roche cobas Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay
• Z-0542-2009 · Sep 15, 2008 · Terminated
  Roche ISE Internal Standard Gen.2 for use on Roche cobas c systems, Roche Diagnostics, Inc., Indpls., IN; Catalog no. 04522320190. Product is an in vitro diagnostic.
• Z-0576-2008 · Dec 4, 2007 · Terminated
  Roche COBAS 6000 Clinical Chemistry analyzer; Catalog Number: 04745914001, Roche Diagnostics Corporation, Indianapolis, IN 46250.