Roche 9180 Electrolyte Analyzer 3157334001Recalls & reported problems

Summary

The FDA's MAUDE database contains 50 adverse event reports that list this exact device (DI 04015630031832), received between Aug 6, 2018 and Apr 23, 2026 — classified as 50 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (24 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. 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 25 most recent of 50 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 23, 2026Incorrect, Inadequate or Imprecise Result or Readings

  THE INITIAL REPORTER COMPLAINED OF DISCREPANT LOW RESULTS FOR 2 PATIENT SAMPLES TESTED FOR SODIUM (NA) ON A ROCHE 9180 ELECTROLYTE ANALYZER. PATIENT 1 INITIAL RESULT WAS 109 MMOL/L. THE REPEAT RESULT WAS 136 MMOL/L. PATIENT 2 INITIAL RESULT WAS 112 MMOL/L. THE REPEAT RESULT WAS 141 MMOL/L. RECALIBRATION WAS PERFORMED BETWEEN THE INITIAL AND REPEAT RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24969781 ↗
• MalfunctionDec 4, 2025Incorrect Measurement; Incorrect Measurement

  THERE WAS AN ALLEGATION OF QUESTIONABLE ROCHE 9180 POTASSIUM ELECTRODE RESULTS FOR 1 PATIENT SAMPLE ON A ROCHE 9180 ELECTROLYTE ANALYZER. THE CUSTOMER WAS PROMPTED TO REPEAT THE PATIENT SAMPLE AS THE INITIAL RESULT DID NOT MATCH THE PATIENT'S CLINICAL HISTORY. THE INITIAL RESULT WAS 5.2 MMOL/L. THE REPEAT RESULT WAS 4.4 MMOL/L. THE REPEAT RESULT WAS DEEMED CORRECT. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23717870 ↗
• MalfunctionNov 21, 2025Incorrect, Inadequate or Imprecise Result or Readings; Non Reproducible Results; Incorrect, Inadequate or Imprecise Result or Readings; Non Reproducible Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE ROCHE 9180 SODIUM ELECTRODE RESULT FROM THE ROCHE 9180 ELECTROLYTE ANALYZER FOR ONE PATIENT. THE INITIAL RESULT WAS 109 MMOL/L, AND THE REPEAT RESULT AT ANOTHER LAB WITH AN UNKNOWN ANALYZER WAS 138 MMOL/L. THE CUSTOMER SENT THE PATIENT TO ANOTHER LAB TO CONFIRM AFTER RECEIVING A LOW INITIAL RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23618817 ↗
• MalfunctionNov 18, 2025Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results; Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE SODIUM ELECTRODE RESULTS WITH MULTIPLE PATIENT SAMPLES ON A ROCHE 9180 ELECTROLYTE ANALYZER. THE FOLLOWING EXAMPLE FOR ONE PATIENT WAS PROVIDED: THE INITIAL RESULT WAS 113 MMOL/L. THE REPEAT RESULTS WERE 113 MMOL/L AND 139 MMOL/L, RESPECTIVELY. THE NORMAL RESULT WAS DEEMED CORRECT (139 MMOL/L).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23585450 ↗
• MalfunctionNov 10, 2025Product Quality Problem; Incorrect, Inadequate or Imprecise Result or Readings; Product Quality Problem; Incorrect, Inadequate or Imprecise Result or Readings

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH THE ROCHE 9180 SODIUM ELECTRODE ON A ROCHE 9180 ELECTROLYTE ANALYZER. THE SAMPLE WAS TESTED FIVE TIMES, RESULTING IN THE FOLLOWING SODIUM VALUES: 139 MMOL/L, 138 MMOL/L, 138 MMOL/L, 138 MMOL/L, AND 138 MMOL/L. THE SAMPLE WAS TESTED TWO ADDITIONAL TIMES ON A BACKUP 9180 INSTRUMENT, RESULTING IN SODIUM VALUES OF 114 MMOL/L WITH A DATA FLAG AND 112 MMOL/L WITH A DATA FLAG. THESE REPEAT VALUES WERE APPROPRIATE FOR THE PATIENT'S CLINICAL CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23512178 ↗
• MalfunctionNov 10, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH THE SODIUM ELECTRODE ON A ROCHE 9180 ELECTROLYTE ANALYZER. THE SAMPLE INITIALLY RESULTED IN A SODIUM VALUE OF 110 MMOL/L. THE SYSTEM WAS RE-CALIBRATED AND THE SAMPLE WAS REPEATED, RESULTING IN A VALUE OF 139 MMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23509020 ↗
• MalfunctionNov 4, 2025Incorrect, Inadequate or Imprecise Result or Readings; Non Reproducible Results; Incorrect, Inadequate or Imprecise Result or Readings; Non Reproducible Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE SODIUM ELECTRODE RESULT FROM THE ROCHE 9180 ELECTROLYTE ANALYZER FOR TWO PATIENTS. PATIENT 1'S INITIAL RESULT WAS 134 MMOL/L, AND THE REPEAT RESULT WAS 143 MMOL/L. PATIENT 2'S INITIAL RESULT WAS 132 MMOL/L, AND THE REPEAT RESULT WAS 149 MMOL/L. THE CUSTOMER IS UNSURE WHICH RESULTS ARE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23464178 ↗
• MalfunctionNov 4, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED FOR SODIUM ON A ROCHE 9180 ELECTROLYTE ANALYZER. INITIAL RESULT: 125 MMOL/L. THE CUSTOMER OBSERVED CRYSTALLIZATION AROUND THE REFERENCE ELECTRODE AND NOTICED THAT THE INITIAL RESULT DID NOT CORRELATE WITH THE PATIENT'S CONDITION, AND REPEATED THE SAMPLE. REPEAT RESULT: 140 MMOL/L (TESTED ON A COBAS PURE INSTRUMENT). THE REPEAT RESULT WAS DEEMED TO BE CORRECT. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23464157 ↗
• MalfunctionSep 19, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE INITIAL REPORTER COMPLAINED OF A DISCREPANT LOW RESULT FOR 1 PATIENT SAMPLE TESTED WITH ROCHE 9180 SODIUM ELECTRODE (NA) ON A ROCHE 9180 ELECTROLYTE ANALYZER. THE INITIAL RESULT ON THE 9180 ANALYZER WAS 104 MMOL/L. THE REPEAT ON A COBAS PRO ANALYZER WAS 138.2 MMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23097649 ↗
• MalfunctionSep 9, 2025Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT SODIUM ELECTRODE RESULTS FOR TWO PATIENT SAMPLES TESTED ON A ROCHE 9180 ELECTROLYTE ANALYZER. THE SECOND SAMPLE ALSO HAD DISCREPANT CHLORIDE ELECTRODE RESULTS. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE FIRST PATIENT SAMPLE RESULTED IN SODIUM VALUES OF 140 MMOL/L, 192.6 MMOL/L, AND 146.3 MMOL/L WITH A DATA FLAG. THE SECOND PATIENT SAMPLE RESULTED IN SODIUM VALUES OF 137.8 MMOL/L, 161.4 MMOL/L WITH A DATA FLAG, AND 173.1 MMOL/L WITH A DATA FLAG. THIS SAMPLE RESULTED IN CHLORIDE VALUES OF 108.8 MMOL/L, 96.2 MMOL/L WITH A DATA FLAG, AND 97.2 MMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23009086 ↗
• MalfunctionSep 8, 2025Low Test Results; Output Problem; Low Test Results; Output Problem

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 5 PATIENTS' SAMPLES TESTED FOR SODIUM (NA) ON A ROCHE 9180 ELECTROLYTE ANALYZER WHEN COMPARED TO A DIFFERENT FACILITY. DISCREPANT RESULTS FOR 1 PATIENT SAMPLE WERE PROVIDED. SAMPLE 1: INITIAL RESULT: 120 MMOL/L. PER THE CUSTOMER'S GUIDELINES, THE CUSTOMER REPEATED THE SAMPLE AS IT WAS CONSIDERED CRITICAL LOW. 1ST REPEAT RESULT: 120 MMOL/L. 2ND REPEAT RESULT: 119 MMOL/L (TESTED FROM A 2ND TUBE). DURING THE EVALUATION PROCESS OF A NEW QC, THE CUSTOMER SUSPECTED A FAULT. THE CUSTOMER THEN RANDOMLY PICKED UP 5 PATIENTS' SAMPLES, INCLUDING SAMPLE 1, AND SENT THEM TO A DIFFERENT FACILITY TO BE REPEATED. 3RD REPEAT RESULT OF SAMPLE 1: 141 MMOL/L (TESTED ON A COBAS PRO AT A DIFFERENT FACILITY). THE REPEAT RESULTS TESTED AT THE DIFFERENT FACILITY WERE DEEMED TO BE CORRECT. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22994823 ↗
• MalfunctionSep 2, 2025Incorrect, Inadequate or Imprecise Result or Readings; Non Reproducible Results; Incorrect, Inadequate or Imprecise Result or Readings; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR TWO PATIENT SAMPLES TESTED WITH THE ROCHE 9180 SODIUM ELECTRODE ON A ROCHE 9180 ELECTROLYTE ANALYZER. THE CUSTOMER NOTED THAT THE ISSUE OCCURS AFTER THEY CHANGE A SYSTEM REAGENT PACK. THE CUSTOMER ALSO MENTIONED THAT THE ELECTRODES WERE REPLACED RECENTLY. THE SYSTEM REAGENT PACK WAS REPLACED, MAINTENANCE WAS PERFORMED, AND THE SYSTEM WAS CALIBRATED. THE SAMPLE ISSUES OCCURRED AFTER THESE ACTIONS. THE FIRST SAMPLE INITIALLY RESULTED IN A SODIUM VALUE OF 144 MMOL/L AND IT REPEATED AS 126 MMOL/L. THE SECOND SAMPLE INITIALLY RESULTED IN A SODIUM VALUE OF 141 MMOL/L AND IT REPEATED AS 125 MMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22937196 ↗
• MalfunctionSep 2, 2025Mechanical Problem; Mechanical Problem

  THERE WAS AN ALLEGATION OF QUESTIONABLE LITHIUM RESULTS FROM THE ROCHE 9180 ELECTROLYTE ANALYZER FOR 8 PATIENTS. PATIENT 1'S INITIAL RESULT WAS 0.76 MMOL/L, AND THE REPEAT RESULT WAS 1.15 MMOL/L. PATIENT 2'S INITIAL RESULT WAS 0.20 MMOL/L, AND THE REPEAT RESULT WAS 0.94 MMOL/L. PATIENT 3'S INITIAL RESULT WAS 0.30 MMOL/L, AND THE REPEAT RESULT WAS 0.57 MMOL/L. PATIENT 4'S INITIAL RESULT WAS 0.28 MMOL/L, AND THE REPEAT RESULT WAS 0.51 MMOL/L. PATIENT 5'S INITIAL RESULT WAS 0.39 MMOL/L, AND THE REPEAT RESULT WAS 0.68 MMOL/L. PATIENT 6'S INITIAL RESULT WAS 0.26 MMOL/L, AND THE REPEAT RESULT WAS 0.66 MMOL/L. PATIENT 7'S INITIAL RESULT WAS 0.97 MMOL/L, AND THE REPEAT RESULT WAS 1.27 MMOL/L. PATIENT 8'S INITIAL RESULT WAS 1.45 MMOL/L, AND THE REPEAT RESULT WAS 0.40 MMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22936804 ↗
• MalfunctionAug 25, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THERE WAS AN ALLEGATION OF QUESTIONABLE SODIUM RESULTS FROM THE ELECTROLYTE ANALYZER W/O STARTERKIT 9180. EXAMPLE 1 INITIAL RESULT WAS 115 MMOL/L, AND THE REPEAT RESULTS WERE 136 MMOL/L AND 137 MMOL/L. EXAMPLE 2 INITIAL RESULT WAS 114 MMOL/L, AND THE REPEAT RESULTS WERE 115 MMOL/L AND 141 MMOL/L. THE QUESTIONABLE RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22882784 ↗
• MalfunctionAug 15, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE INITIAL REPORTER COMPLAINED OF LOW RESULTS FOR MULTIPLE PATIENT SAMPLES TESTED WITH A ROCHE 9180 SODIUM ELECTRODE (NA) ON A ROCHE 9180 ELECTROLYTE ANALYZER. A DISCREPANT LOW RESULT WAS PROVIDED FOR 1 PATIENT SAMPLE TESTED USING A NEW NA ELECTRODE AND A PREVIOUS NA ELECTRODE. THE RESULT USING THE PREVIOUS NA ELECTRODE WAS 131 MMOL/L. THE RESULT USING THE NEW NA ELECTRODE WAS 116 MMOL/L. THE RESULTS USING THE NEW NA ELECTRODE ARE IN QUESTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22817663 ↗
• MalfunctionAug 11, 2025Low Test Results; Low Test Results

  THERE WAS AN ALLEGATION OF 3 QUESTIONABLE SODIUM ELECTRODE RESULTS FROM THE ROCHE 9180 ELECTROLYTE ANALYZER. PATIENT 1'S INITIAL RESULT WAS 118 MMOL/L, AND THE REPEAT RESULT FROM A COBAS PURE WAS 137 MMOL/L. PATIENT 2'S INITIAL RESULT WAS 121 MMOL/L, AND THE REPEAT RESULT FROM A COBAS PURE WAS 138 MMOL/L. PATIENT 3'S INITIAL RESULT WAS 118 MMOL/L, AND THE REPEAT RESULT FROM A COBAS PURE WAS 137 MMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22777170 ↗
• MalfunctionJul 31, 2025Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE RESULTS FOR AN UNSPECIFIED NUMBER OF PATIENT SAMPLES TESTED ON A ROCHE 9180 ELECTROLYTE ANALYZER. RESULTS FROM THE ANALYZER DID NOT AGREE WITH THE CLINICAL CONDITION OF PATIENTS. THE CUSTOMER PROVIDED DATA FOR ONE PATIENT SAMPLE WITH DISCREPANT SODIUM ELECTRODE RESULTS. THE SAMPLE INITIALLY RESULTED IN A SODIUM VALUE OF 128.5 MMOL/L. THE SAMPLE WAS REPEATED TWICE, RESULTING IN VALUES OF 134.3 MMOL/L AND 137.5 MMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22674631 ↗
• MalfunctionJul 28, 2025Incorrect Measurement; Incorrect, Inadequate or Imprecise Result or Readings; Incorrect Measurement; Incorrect, Inadequate or Imprecise Result or Readings

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT SODIUM ELECTRODE RESULTS FOR ONE PATIENT SAMPLE TESTED ON A ROCHE 9180 ELECTROLYTE ANALYZER. THE SAMPLE INITIALLY RESULTED IN A SODIUM VALUE OF 142 MMOL/L AND IT REPEATED AS 170 MMOL/L. THE CUSTOMER DID NOT BELIEVE ANY OF THE VALUES TO BE CORRECT. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY AS THE RESULTS DID NOT MATCH THE PATIENT'S CLINICAL CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22628877 ↗
• MalfunctionJul 18, 2025Low Test Results; Low Test Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE SODIUM ELECTRODE AND POTASSIUM ELECTRODE RESULTS FROM PATIENT SAMPLES TESTED ON THE ROCHE 9180 ELECTROLYTE ANALYZER. THE FOLLOWING ARE EXAMPLES OF DISCREPANT RESULTS: THE INITIAL SODIUM RESULT WAS 109 MMOL/L WITH A DATA FLAG. THE REPEAT RESULT WAS 135 MMOL/L WITH A DATA FLAG. A REPEAT RESULT OF 107 MMOL/L WITH A DATA FLAG WAS ALSO REPORTED. IT IS NOT CLEAR IF THE FOLLOWING RESULTS ARE FROM THE SAME PATIENT SAMPLE: THE INITIAL POTASSIUM RESULT WAS 3.7 MMOL/L. THE REPEAT RESULT WAS 4.2 MMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22540474 ↗
• MalfunctionJul 14, 2025Incorrect Measurement; Low Test Results; Incorrect Measurement; Low Test Results

  WE RECEIVED AN ALLEGATION OF QUESTIONABLE ION-SELECTIVE ELECTRODE (ISE) RESULTS FOR 2 PATIENTS¿ SAMPLES TESTED ON A ROCHE 9180 ELECTROLYTE ANALYZER. RESULTS FOR THE SODIUM (NA) TEST WERE AFFECTED. SAMPLE 1: NA: INITIAL RESULT: 109 MMOL/L. REPEAT RESULT: 142 MMOL/L. SAMPLE 2: NA: INITIAL RESULT: 107 MMOL/L. REPEAT RESULT: 136 MMOL/L. THE CUSTOMER QUESTIONED THE INITIAL RESULTS AND REPEATED THE SAMPLES. THE REPEAT RESULTS WERE DEEMED TO BE CORRECT. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22494499 ↗
• MalfunctionJul 11, 2025Incorrect Measurement; Incorrect, Inadequate or Imprecise Result or Readings; Incorrect Measurement; Incorrect, Inadequate or Imprecise Result or Readings

  WE RECEIVED AN ALLEGATION OF QUESTIONABLE ION-SELECTIVE ELECTRODE (ISE) RESULTS FOR 3 PATIENTS¿ SAMPLES TESTED ON A ROCHE 9180 ELECTROLYTE ANALYZER. RESULTS FOR THE FOLLOWING TESTS WERE AFFECTED: SODIUM (NA), POTASSIUM (K) AND CHLORIDE (CL). SAMPLE 1: NA: INITIAL RESULT: 145.3 MMOL/L. REPEAT RESULT: 138.6 MMOL/L. K: INITIAL RESULT: 1.73 MMOL/L. REPEAT RESULT: 5.47 MMOL/L. SAMPLE 2: CL: INITIAL RESULT: 124.1 MMOL/L. REPEAT RESULT: 110.1 MMOL/L. SAMPLE 3: NA: INITIAL RESULT: 152.0 MMOL/L. REPEAT RESULT: 139.1 MMOL/L. THE CUSTOMER QUESTIONED THE INITIAL RESULTS AND REPEATED THE SAMPLES. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22478451 ↗
• MalfunctionJul 3, 2025Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results; Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE NA ELECTRODE RESULTS FOR 3 PATIENT SAMPLES ON A ROCHE 9180 ELECTROLYTE ANALYZER. PATIENT 1: THE INITIAL RESULT WAS 107 MMOL/L, AND THE REPEATED RESULT WAS 141 MMOL/L. PATIENT 2: THE INITIAL RESULT WAS 105 MMOL/L, AND THE REPEATED RESULT WAS 139 MMOL/L. PATIENT 3: THE INITIAL RESULT WAS 104 MMOL/L, AND THE REPEATED RESULT WAS 140 MMOL/L. THE REPEATED RESULTS WERE OBTAINED IN ANOTHER LABORATORY USING AN UNKNOWN METHOD. THE SAMPLES WERE REPEATED BECAUSE THE INITIAL RESULTS DID NOT MATCH THE CLINICAL STATUS OF THE PATIENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22393538 ↗
• MalfunctionJun 30, 2025Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results; Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ROCHE 9180 SODIUM ELECTRODE RESULTS FROM TWO PATIENT SAMPLES TESTED ON THE ELECTROLYTE ANALYZER W/O STARTERKIT 9180. PATIENT SAMPLE 1 THE INITIAL RESULT WAS 113 MMOL/L WITH A DATA FLAG. THE REPEAT RESULT WAS 139 MMOL/L. PATIENT SAMPLE 2 THE HIGH RESULT WAS 141 MMOL/L. THE LOW RESULT WAS 115 MMOL/L WITH A DATA FLAG. THE LOW RESULTS WERE INCONSISTENT WITH THE PATIENTS' CLINICAL STATE. THE QUESTIONABLE RESULTS WERE NOT REPORTED OUTSIDE THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22356701 ↗
• MalfunctionJun 23, 2025Unable to Obtain Readings; Incorrect, Inadequate or Imprecise Result or Readings; Unable to Obtain Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ROCHE 9180 SODIUM ELECTRODE RESULTS FROM TWO PATIENT SAMPLES TESTED ON THE ELECTROLYTE ANALYZER W/O STARTERKIT 9180. PATIENT SAMPLE 1: THE INITIAL RESULT USING AN OLD REFERENCE ELECTRODE WITH A NON-ROCHE REFERENCE ELECTRODE HOUSING WAS 93.000 MMOL/L. THE REPEAT RESULT USING A NEW REFERENCE ELECTRODE WITH A NON-ROCHE REFERENCE ELECTRODE HOUSING WAS 142.000 MMOL/L. PATIENT SAMPLE 2: THE HIGH RESULT WAS 113.000 MMOL/L. THE LOW RESULT WAS 102.000 MMOL/L. THE QUESTIONABLE RESULTS WERE NOT REPORTED OUTSIDE THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22306541 ↗
• MalfunctionJun 17, 2025Incorrect Measurement; Low Test Results; Incorrect Measurement; Low Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH THE SODIUM ELECTRODE ON A ROCHE 9180 ELECTROLYTE ANALYZER. THE SAMPLE INITIALLY RESULTED IN A SODIUM VALUE OF 119 MMOL/L. WHEN REPEATED ON THE ANALYZER, THE RESULT IS THE SAME. THE SAMPLE WAS REPEATED ON A COULTER ANALYZER AND THE RESULT WAS 136 MMOL/L. IT WAS ASKED, BUT IT IS NOT KNOWN IF THE SAME SAMPLE WAS USED FOR THE ROCHE 9180 AND COULTER MEASUREMENTS. THE CUSTOMER STATED ANOTHER SAMPLE WAS COLLECTED FROM THE PATIENT AND THE SODIUM RESULT FROM THIS SAMPLE WAS NORMAL. ADDITIONAL SODIUM MEASUREMENTS OF 122 MMOL/L, 122 MMOL/L, AND 118.0 MMOL/L MEASURED ON (B)(6) 2025 WERE PROVIDED. IT WAS ASKED, BUT IT IS NOT KNOWN IF THESE WERE VALUES FROM THE SAME COMPLAINED PATIENT SAMPLE OR IF THESE WERE MEASUREMENTS OF OTHER PATIENT SAMPLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22232572 ↗