Chloride ElectrodeRecalls & reported problems across all models

We found 3 models of Chloride Electrode by Roche Diagnostics GmbH in the FDA's device registry (GUDID). Together they are named in 30 adverse event reports in the FDA's MAUDE database, received between Aug 10, 2018 and Mar 18, 2026 — classified as 30 malfunctions.

The most frequently reported specific device problem is “High Test Results” (12 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Chloride Electrode problems

Chloride Electrode models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Chloride Electrode 3003523001

  ELECTRODE, ION-SPECIFIC, CHLORIDE
  13 reports
• Chloride Electrode 3246353001

  ELECTRODE, ION-SPECIFIC, CHLORIDE
  13 reports
• Chloride electrode 03246353001

  ELECTRODE, ION-SPECIFIC, CHLORIDE
  4 reports

Recent Chloride Electrode adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionMar 18, 2026Incorrect Measurement; Incorrect, Inadequate or Imprecise Result or Readings

  THERE WAS AN ALLEGATION OF QUESTIONABLE SODIUM ELECTRODE (NA), POTASSIUM ELECTRODE (K), AND ISE INDIRECT NA-K-CL FOR GEN.2 (CL) RESULTS FOR 1 PATIENT SAMPLE ON A COBAS 6000 C (501) MODULE. THIS MEDWATCH WILL COVER CHLORIDE. REFER TO MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE SODIUM RESULTS AND MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE POTASSIUM RESULTS. THE INITIAL NA RESULT WAS 123 MMOL/L, THE INITIAL K RESULT WAS 3.42 MMOL/L, AND THE INITIAL CL RESULT WAS 116.9 MMOL/L. THE CUSTOMER QUESTIONED THE RESULTS AS THEY WERE ACCOMPANIED BY A NEGATIVE ION GAP WHICH PROMPTED THEM TO REPEAT THE RESULTS. THE REPEAT NA RESULT WAS 137 MMOL/L, THE REPEAT K RESULT WAS 4.21 MMOL/L, AND THE REPEAT CL RESULT WAS 102.5 MMOL/L. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE REPEAT RESULTS WERE DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24626127 ↗
• MalfunctionJan 7, 2026High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ISE INDIRECT NA-K-CL FOR GEN.2 (CL), POTASSIUM ELECTRODE (K), AND SODIUM ELECTRODE (NA) RESULTS FOR 5 PATIENT SAMPLES ON A COBAS 8000 COBAS ISE MODULE. THIS MEDWATCH WILL COVER CL. REFER TO MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE K RESULTS AND MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE NA RESULTS. THE CUSTOMER HAD NOTICED AN INCREASED FREQUENCY OF HIGH RESULTS WHICH PROMPTED THEM TO REPEAT PATIENT SAMPLES. FOR SAMPLE 1, THE INITIAL NA RESULT WAS 167 MMOL/L, THE INITIAL K RESULT WAS 5.2 MMOL/L, AND THE INITIAL CL RESULT WAS 123 MMOL/L. THE SAMPLE WAS REPEATED ON ANOTHER ANALYZER AND THE NA RESULT WAS 141 MMOL/L, THE K RESULT WAS 4.5 MMOL/L, AND THE CL RESULT WAS 108 MMOL/L. FOR SAMPLE 2, THE INITIAL NA RESULT WAS 244 MMOL/L AND THE INITIAL K RESULT WAS 7.8 MMOL/L. THE SAMPLE WAS REPEATED ON ANOTHER ANALYZER. THE NA RESULT WAS 140 MMOL/L AND THE K RESULT WAS 4.1 MMOL/L. FOR SAMPLE 3, THE INITIAL NA RESULT WAS 220 MMOL/L, THE INITIAL K RESULT WAS 8.4 MMOL/L, AND THE INITIAL CL RESULT WAS 166 MMOL/L. THE SAMPLE WAS REPEATED ON ANOTHER ANALYZER AND THE NA RESULT WAS 131 MMOL/L, THE K RESULT WAS 5.3

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23987883 ↗
• MalfunctionDec 17, 2025Low Test Results; Low Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ISE INDIRECT NA-K-CL FOR GEN.2 RESULTS FOR 1 PATIENT SAMPLE ON A COBAS 6000 C (501) MODULE. THIS MEDWATCH WILL COVER CHLORIDE. REFER TO MEDWATCH WITH A1 PATIENT IDENTIFIER: (B)(6) FOR INFORMATION ON THE SODIUM RESULTS AND MEDWATCH WITH A1 PATIENT IDENTIFIER: (B)(6) FOR INFORMATION ON THE POTASSIUM RESULTS. THE INITIAL NA RESULT WAS 104 MMOL/L, THE INITIAL K RESULT WAS 3.5 MMOL/L, AND THE INITIAL CL RESULT WAS 73.2 MMOL/L. THE CUSTOMER QUESTIONED THE RESULTS WHICH PROMPTED THEM TO REPEAT THE SAMPLE. THE SAMPLE WAS REPEATED ON ANOTHER C 501 ANALYZER AND THE NA RESULT WAS 129 MMOL/L, THE K RESULT WAS 4.32 MMOL/L, AND THE CL RESULT WAS 94.3 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 23830474 ↗
• MalfunctionNov 12, 2025High Test Results; High Test Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECTRODE T7, CHLORIDE RESULTS FROM SEVERAL PATIENT SAMPLES TESTED ON THE COBAS INTEGRA 400 PLUS. ONE EXAMPLE OF A QUESTIONABLE RESULT WAS PROVIDED: THE INITIAL RESULT FROM THE ANALYZER WAS 116.5 MMOL/L. THE REPEAT RESULT FROM ANOTHER COBAS INTEGRA 400 PLUS ANALYZER WAS 105.4 MMOL/L. THE REPORTER NOTED AN ANION GAP OF -3, PROMPTING THE RERUN. THE REPEAT RESULT WAS DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23532787 ↗
• MalfunctionJul 30, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  WE RECEIVED AN ALLEGATION ABOUT QUESTIONABLE CHLORIDE (CL) TEST RESULTS FOR AN UNSPECIFIED NUMBER OF PATIENTS' SAMPLES TESTED ON THE ROCHE 9180 ELECTROLYTE ANALYZER. THE REPORTER STATED THAT THE RESULTS DID NOT MATCH THE PATIENTS' CLINICAL PICTURES. THE REPORTER PROVIDED THE FOLLOWING EXAMPLES OF DISCREPANT RESULTS: PATIENT 1: INITIAL RESULT: 107.8 MMOL/L. REPEAT RESULT: 104.8 MMOL/L. PATIENT 2: INITIAL RESULT: 107.4 MMOL/L. REPEAT RESULT: 103.8 MMOL/L. PATIENT 3: INITIAL RESULT: 111.3 MMOL/L. REPEAT RESULT: 113.0 MMOL/L. PATIENT 4: INITIAL RESULT: 110.6 MMOL/L. REPEAT RESULT: 107.4 MMOL/L. PATIENT 5: INITIAL RESULT: 105 MMOL/L. REPEAT RESULT: 108.3 MMOL/L. ON (B)(6) 2025: PATIENT 6: INITIAL RESULT: 111.1 MMOL/L. REPEAT RESULT: 111.2 MMOL/L. ON (B)(6) 2025: PATIENT 7: INITIAL RESULT: 112.5 MMOL/L. REPEAT RESULT: 112.2 MMOL/L. PATIENT 8: INITIAL RESULT: 112.9 MMOL/L. REPEAT RESULT: 113.2 MMOL/L. PATIENT 9: INITIAL RESULT: 112 MMOL/L. REPEAT RESULT: 112.1 MMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22668196 ↗
• MalfunctionMay 13, 2025Non Reproducible Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ISE SODIUM ELECTRODE RESULTS FOR 12 PATIENT SAMPLES AND QUESTIONABLE CHLORIDE ELECTRODE RESULTS FOR 1 PATIENT SAMPLE ON A COBAS 8000 ISE 1800 MODULE. THIS MEDWATCH WILL APPLY TO THE CHLORIDE ELECTRODE. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE ISE SODIUM ELECTRODE. PATIENT 1: THE INITIAL NA RESULT IS 147 MMOL/L, AND THE REPEATED RESULT WAS 140 MMOL/L. PATIENT 2: THE INITIAL NA RESULT IS 144 MMOL/L, AND THE REPEATED RESULT WAS 134 MMOL/L. PATIENT 3: THE INITIAL NA RESULT IS 152 MMOL/L, AND THE REPEATED RESULT WAS 145 MMOL/L. PATIENT 4: THE INITIAL NA RESULT IS 145 MMOL/L, AND THE REPEATED RESULT WAS 137 MMOL/L. PATIENT 5: THE INITIAL NA RESULT IS 153 MMOL/L, AND THE REPEATED RESULT WAS 146 MMOL/L. PATIENT 6: THE INITIAL NA RESULT IS 150 MMOL/L, AND THE REPEATED RESULT WAS 143 MMOL/L. PATIENT 7: THE INITIAL NA RESULT IS 150 MMOL/L, AND THE REPEATED RESULT WAS 142 MMOL/L. PATIENT 8: THE INITIAL NA RESULT IS 150 MMOL/L, AND THE REPEATED RESULT WAS 142 MMOL/L. PATIENT 9: THE INITIAL NA RESULT IS 151 MMOL/L, AND THE REPEATED RESULT WAS 144 MMOL/L. PATIENT 10: THE INITIAL NA RESULT IS 142 MMOL/L,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22013232 ↗
• MalfunctionOct 9, 2024Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results; Non Reproducible Results; Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results; Non Reproducible Results

  WE RECEIVED AN ALLEGATION OF QUESTIONABLE ISE RESULTS FOR 1 PATIENT SAMPLE TESTED ON A COBAS 6000 C (501) MODULE WHEN COMPARED TO AN INTEGRA 400 PLUS ANALYZER. RESULTS FOR THE FOLLOWING TESTS WERE AFFECTED: SODIUM (NA) AND CHLORIDE (CL). NA: INITIAL RESULT: 123 MMOL/L. REPEAT RESULT: 137 MMOL/L (TESTED ON INTEGRA 400 PLUS). CL: INITIAL RESULT: 81.7 MMOL/L. REPEAT RESULT: 95 MMOL/L (TESTED ON INTEGRA 400 PLUS). THE INITIAL RESULTS WERE REPORTED OUTSIDE THE LABORATORY AND THEY DID NOT MATCH THE PATIENT'S HISTORY. THE SAMPLE WAS THEN REPEATED AND THE REPEAT RESULTS WERE DEEMED TO BE CORRECT. REPORTEDLY, THE CUSTOMER CALLED THE PHYSICIAN AND CORRECTED THE RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20409088 ↗
• MalfunctionJul 18, 2024Low Test Results; Low Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE GEN.2 ISE INDIRECT FOR NA AND CL RESULTS FOR 1 PATIENT PLASMA SAMPLE ON A COBAS 6000 C (501) MODULE. THIS MEDWATCH WILL COVER CL. REFER TO MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE NA RESULTS. THE INITIAL NA RESULT WAS 119 MMOL/L AND THE INITIAL CL RESULT WAS 118.2 MMOL/L. THE CUSTOMER QUESTIONED THE INITIAL RESULTS AS THEY WERE DEEMED CRITICAL AND WAS PROMPTED TO REPEAT THE SAMPLE. THE SAMPLE WAS REPEATED ON ANOTHER C501 ANALYZER AND THE NA RESULT WAS 136 MMOL/L AND THE CL RESULT WAS 102 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 19773120 ↗
• 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. THIS MEDWATCH WILL APPLY TO THE CL ELECTRODE. REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE NA 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 CL 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 K 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 REPEATED. NEITHER THE INITIAL OR REPEAT VALUES WERE DEEMED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19511492 ↗
• MalfunctionMar 4, 2024High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ISE INDIRECT GEN 2 RESULTS FROM THE COBAS 6000 C 501. THE INITIAL SODIUM RESULT WAS 105 MMOL/L WITH A DATA FLAG AND THE REPEAT RESULT WAS 137 MMOL/L. THE INITIAL CHLORIDE RESULT WAS 131.1 MMOL/L WITH A DATA FLAG AND THE REPEAT RESULT WAS 98.4 MMOL/L. THE QUESTIONABLE RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THE REPEAT RESULTS WERE BELIEVED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18831713 ↗
• MalfunctionFeb 16, 2024Output Problem; Output Problem

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH THE CHLORIDE ELECTRODE ON A COBAS INTEGRA 400 PLUS. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE RESULTED IN A CL VALUE OF 120 MMOL/L WHEN TESTED ON THE INTEGRA 400 PLUS ANALYZER. THE SAMPLE WAS REPEATED ON AN UNKNOWN GASOMETER INSTRUMENT, RESULTING IN A CL VALUE OF 109 MMOL/L. THIS VALUE WAS CONSIDERED TO BE CORRECT BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18720798 ↗
• MalfunctionFeb 13, 2024Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Incorrect, Inadequate or Imprecise Result or Readings; High Test Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ISE INDIRECT CI FOR GEN.2 RESULTS FROM 20 PATIENT SAMPLES TESTED ON THE COBAS INTEGRA 400 PLUS. THE INITIAL RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THE REPORTER NOTED THAT THE CL RESULTS WERE RUNNING HIGH COMPARED TO THE PATIENT HISTORY PROMPTING THE RERUN OF THE PATIENT SAMPLES. THE REPORTER WAS ABLE TO PROVIDE TWO EXAMPLES OF DISCREPANT RESULTS: SAMPLE 1 THE INITIAL CL RESULT WAS 122 MMOL/L. THE REPEAT RESULT WAS 105 MMOL/L. SAMPLE 2 THE INITIAL CL RESULT WAS 118 MMOL/L. THE REPEAT RESULT WAS 106 MMOL/L. THE REPEAT RESULTS WERE DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18693992 ↗
• MalfunctionFeb 8, 2024Incorrect, 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, K, AND CL RESULTS FOR 1 SAMPLE, QUESTIONABLE NA ELECTRODE, K RESULTS FOR 1 SAMPLE, AND QUESTIONABLE NA ELECTRODE RESULTS FOR 4 SAMPLES ON A COBAS 6000 C 501 MODULE. SAMPLE 1: (B)(6). THE INITIAL NA RESULT WAS 124 MMOL/L AND THE REPEATED RESULT WAS 138 MMOL/L. THE INITIAL K RESULT WAS 3.90 MMOL/L AND THE REPEATED RESULT WAS 4.45 MMOL/L. THE INITIAL CL RESULT WAS 88.6 MMOL/L AND THE REPEATED RESULT WAS 98.4 MMOL/L. SAMPLE 2: (B)(6). THE INITIAL NA RESULT WAS 123 MMOL/L AND THE REPEATED RESULT WAS 137 MMOL/L. THE INITIAL K RESULT WAS 3.86 MMOL/L AND THE REPEATED RESULT WAS 4.28 MMOL/L. SAMPLE 3: (B)(6). THE INITIAL NA RESULT WAS 130 MMOL/L AND THE REPEATED RESULT WAS 140 MMOL/L. SAMPLE 4: (B)(6). THE INITIAL NA RESULT WAS 133 MMOL/L. AND THE REPEATED RESULT WAS 142 MMOL/L. SAMPLE 5: (B)(6). THE INITIAL NA RESULT WAS 128 MMOL/L AND THE REPEATED RESULT WAS 135 MMOL/L. SAMPLE 6: (B)(6). THE INITIAL NA RESULT WAS 130 MMOL/L AND THE REPEATED RESULT WAS 138 MMOL/L. THE REPEATED RESULTS WERE OBTAINED USING AN ALTERNATE INSTRUMENT AND THEY WERE BELIEVED TO BE CORRECT. THE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLES WERE RE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18670752 ↗
• MalfunctionNov 20, 2023Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results; Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results

  THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED FOR CL ELECTRODE (CL) AND SODIUM ELECTRODE (NA) ON A COBAS 6000 C (501) MODULE. THIS MEDWATCH WILL COVER CL. REFER TO MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE NA RESULTS. THE INITIAL CL RESULT WAS 135 MMOL/L. THE SAMPLE WAS REPEATED TWICE WITH RESULTS OF 101 MMOL/L AND 100 MMOL/L. A NEW SAMPLE WAS OBTAINED AND THE CL RESULT WAS 102 MMOL/L. THE INITIAL NA RESULT WAS 110 MMOL/L. THE SAMPLE WAS REPEATED TWICE WITH RESULTS OF 139 MMOL/L. A NEW SAMPLE WAS OBTAINED AND THE NA RESULT WAS 140 MMOL/L. THE REPEAT RESULTS WERE BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18172862 ↗
• MalfunctionNov 14, 2023High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 3 PATIENT SAMPLES TESTED FOR CL ELECTRODE (CL) AND NA ELECTRODE (NA) ON A COBAS PRO ISE ANALYTICAL UNIT. THIS MEDWATCH WILL COVER CL. REFER TO MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE NA RESULTS. PATIENT 1: THE INITIAL NA RESULT WAS 157 MMOL/L. THE REPEAT RESULT WAS 140.7 MMOL/L. THE INITIAL CL RESULT WAS 114 MMOL/L. THE REPEAT RESULT WAS 102.3 MMOL/L. PATIENT 2: THE INITIAL NA RESULT WAS 161 MMOL/L. THE REPEAT RESULT WAS 143.2 MMOL/L. THE INITIAL CL RESULT WAS 118 MMOL/L. THE REPEAT RESULT WAS 104.2 MMOL/L. PATIENT 3: THE INITIAL NA RESULT WAS 167 MMOL/L. THE REPEAT RESULT WAS 157.2 MMOL/L. THE INITIAL CL RESULT WAS 136 MMOL/L. THE REPEAT RESULT WAS 122.6 MMOL/L. THE CUSTOMER NOTICED THE INITIAL RESULTS DID NOT MATCH THE PATIENT¿S PREVIOUS HISTORY AND REPEATED THE SAMPLES ON A DIFFERENT ANALYZER. THE REPEAT RESULTS WERE BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18133648 ↗

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