cobas pro ISE analytical unit 08464537001Recalls & reported problems

Summary

The FDA's MAUDE database contains 148 adverse event reports that list this exact device (DI 07613336158876), received between Aug 3, 2021 and May 15, 2024 — classified as 148 malfunctions.

The most frequently reported specific device problem is “High Test Results” (68 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 148 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 15, 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 HIGH SODIUM RESULTS FROM THE COBAS PRO ISE ANALYTICAL UNIT. PATIENT 1 INITIAL RESULT FROM ANOTHER ANALYZER WAS 139 MMOL/L. THE REPEAT RESULT FROM THE SUSPECT ANALYZER WAS 153 MMOL/L. PATIENT 2 INITIAL RESULT FROM ANOTHER ANALYZER WAS 132 MMOL/L. THE REPEAT RESULT FROM THE SUSPECT ANALYZER WAS 143 MMOL/L. PATIENT 3 INITIAL RESULT FROM ANOTHER ANALYZER WAS 129 MMOL/L. THE REPEAT RESULT FROM THE SUSPECT ANALYZER WAS 135 MMOL/L. PATIENT 4 INITIAL RESULT FROM ANOTHER ANALYZER WAS 142 MMOL/L. THE REPEAT RESULT FROM THE SUSPECT ANALYZER WAS 152 MMOL/L. THE INITIAL RESULTS WERE BELIEVED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19321540 ↗
• MalfunctionFeb 28, 2024Incorrect Measurement; Incorrect Measurement

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH THE NA ELECTRODE ON A COBAS PRO ISE ANALYTICAL UNIT. THE SAMPLE INITIALLY RESULTED IN A NA VALUE OF 151.3 MMOL/L. THE DOCTOR QUESTIONED THE RESULT AND THE SAMPLE WAS REPEATED ON A SECOND ANALYZER. THE REPEAT RESULT WAS 144.8 MMOL/L. THE REPEAT VALUE WAS DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18796593 ↗
• MalfunctionFeb 27, 2024Low Test Results; Low Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE GEN.2 ISE INDIRECT FOR NA AND K RESULTS FOR 12 PATIENT SAMPLES ON A COBAS PRO ISE ANALYTICAL UNIT. THE PATIENTS' DOCTOR QUESTIONED THE RESULTS WHICH PROMPTED THE CUSTOMER TO REPEAT THE PATIENT SAMPLES. FOR SAMPLE 1, THE INITIAL NA RESULT WAS 130.0 MMOL/L. THE SAMPLE WAS REPEATED THE NEXT DAY ON ANOTHER COBAS PRO ANALYZER AND THE REPEAT RESULT WAS 138.3 MMOL/L. FOR SAMPLE 2, THE INITIAL NA RESULT WAS 126.5 MMOL/L. THE SAMPLE WAS REPEATED THE NEXT DAY ON ANOTHER COBAS PRO ANALYZER AND THE REPEAT RESULT WAS 133.5 MMOL/L. FOR SAMPLE 3, THE INITIAL NA RESULT WAS 128.9 MMOL/L. THE SAMPLE WAS REPEATED THE NEXT DAY ON ANOTHER COBAS PRO ANALYZER AND THE REPEAT RESULT WAS 137.1 MMOL/L. FOR SAMPLE 4, THE INITIAL NA RESULT WAS 127.4 MMOL/L. THE SAMPLE WAS REPEATED THE NEXT DAY ON ANOTHER COBAS PRO ANALYZER AND THE REPEAT RESULT WAS 135.4 MMOL/L. FOR SAMPLE 5, THE INITIAL NA RESULT WAS 129.2 MMOL/L. THE SAMPLE WAS REPEATED THE NEXT DAY ON ANOTHER COBAS PRO ANALYZER AND THE REPEAT RESULT WAS 137.4 MMOL/L. FOR SAMPLE 6, THE INITIAL NA RESULT WAS 128.9 MMOL/L. THE SAMPLE WAS REPEATED THE NEXT DAY ON ANOTHER COBAS PRO ANALYZER AND THE REPEAT RESULT WAS 137.6

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18789863 ↗
• MalfunctionFeb 26, 2024Mechanical Problem; Unable to Obtain Readings; Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Mechanical Problem; Unable to Obtain Readings; Incorrect, Inadequate or Imprecise Result or Readings; High Test Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ISE INDIRECT NA FOR GEN.2 RESULTS FROM ELEVEN PATIENT SAMPLES TESTED ON THE COBAS PRO ISE ANALYTICAL UNIT. THE REPORTER WAS ABLE TO PROVIDE ONE EXAMPLE OF A DISCREPANT RESULT. THE INITIAL RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE INITIAL RESULT WAS FLAGGED WITH A DELTA CHECK IN THE LABORATORY INFORMATION SYSTEM (LIS) PROMPTING THE RERUN OF THE PATIENT SAMPLE ON THEIR OTHER ANALYZER. THE INITIAL NA RESULT FROM THE ANALYZER WAS 156 MMOL/L. THE REPEAT RESULT FROM THE OTHER ANALYZER WAS 145 MMOL/L. THE REPEAT RESULT WAS DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18776653 ↗
• MalfunctionFeb 23, 2024Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Output Problem; Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Output Problem

  WE RECEIVED AN ALLEGATION OF QUESTIONABLE ISE RESULTS FOR 4 PATIENTS' SAMPLES TESTED ON A COBAS PRO ISE (COBAS PRO 3) ANALYTICAL UNIT WHEN COMPARED TO A DIFFERENT COBAS PRO ISE (COBAS PRO 2) ANALYTICAL UNIT. RESULTS FOR THE SODIUM (NA) TEST WERE AFFECTED. SAMPLE 1 (PATIENT 1): INITIAL RESULT: 149.9 MMOL/L. REPEAT RESULT: 141.0 MMOL/L (TESTED ON COBAS PRO 2). SAMPLE 2 (PATIENT 2): INITIAL RESULT: 147.6 MMOL/L. REPEAT RESULT: 138.5 MMOL/L (TESTED ON COBAS PRO 2). SAMPLE 3 (PATIENT 3): INITIAL RESULT: 148.3 MMOL/L. REPEAT RESULT: 140.7 MMOL/L (TESTED ON COBAS PRO 2). SAMPLE 4 (PATIENT 4): INITIAL RESULT: 150.0 MMOL/L. REPEAT RESULT: 144.8 MMOL/L (TESTED ON COBAS PRO 2). DUE TO PREVIOUS NA ISSUES ON THE INSTRUMENT, THE SAMPLES WERE REPEATED. REPORTEDLY, AN AMENDED REPORT WITH THE CORRECT RESULTS WAS ISSUED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18766757 ↗
• MalfunctionFeb 21, 2024Low Test Results; Chemical Problem; Low Test Results; Chemical Problem

  THERE WAS AN ALLEGATION OF QUESTIONABLE GEN.2 ISE INDIRECT FOR NA RESULTS FOR 7 PATIENT SAMPLES ON A COBAS PRO ISE ANALYTICAL UNIT. SAMPLE 1 HAD A AN INITIAL RESULT OF 126 MMOL/L AND A REPEAT RESULT OF 139.2 MMOL/L. SAMPLE 2 HAD A AN INITIAL RESULT OF 128 MMOL/L AND A REPEAT RESULT OF 132.4 MMOL/L. SAMPLE 3 HAD A AN INITIAL RESULT OF 127 MMOL/L AND A REPEAT RESULT OF 141.7 MMOL/L. SAMPLE 4 HAD A AN INITIAL RESULT OF 127 MMOL/L AND A REPEAT RESULT OF 138.7 MMOL/L. SAMPLE 5 HAD A AN INITIAL RESULT OF 109 MMOL/L AND A REPEAT RESULT OF 137.8 MMOL/L. SAMPLE 6 HAD A AN INITIAL RESULT OF 128 MMOL/L AND A REPEAT RESULT OF 139.3 MMOL/L. SAMPLE 7 HAD A AN INITIAL RESULT OF 124 MMOL/L AND A REPEAT RESULT OF 134.8 MMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18748299 ↗
• MalfunctionFeb 20, 2024High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE GEN.2 ISE INDIRECT FOR NA RESULTS FOR 1 PATIENT SAMPLE ON A COBAS PRO ISE ANALYTICAL UNIT. THE INITIAL NA RESULT WAS 147 MMOL/L. THE PATIENT'S NURSE QUESTIONED THE RESULTS AND THE SAMPLE WAS REPEATED. THE SAMPLE WAS REPEATED ON ANOTHER ANALYZER AND THE REPEAT RESULT WAS 139.6 MMOL/L. THE REPEAT RESULT WAS DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18738508 ↗
• MalfunctionFeb 20, 2024High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ISE INDIRECT GEN 2 RESULTS FROM THE COBAS PRO ISE ANALYTICAL UNIT. SAMPLE 1 INITIAL SODIUM RESULT WAS 154 MMOL/L AND THE REPEAT RESULT WAS 139 MMOL/L. THE INITIAL CHLORIDE RESULT WAS 117 MMOL/L AND THE REPEAT CHLORIDE RESULT WAS 106 MMOL/L. SAMPLE 2 INITIAL SODIUM RESULT WAS 149 MMOL/L AND THE REPEAT RESULT WAS 139 MMOL/L. SAMPLE 3 INITIAL SODIUM RESULT WAS 149 MMOL/L AND THE REPEAT RESULT WAS 139 MMOL/L. THE REPEAT RESULTS WERE BELIEVED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18738230 ↗
• MalfunctionFeb 19, 2024Non Reproducible Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE NA ELECTRODE RESULTS FOR MANY PATIENT SAMPLES ON A COBAS PRO ISE MODULE. ONE EXAMPLE WAS PROVIDED. THE INITIAL RESULT 153 MMOL/L AND THE REPEATED RESULT WAS 143 MMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18732338 ↗
• MalfunctionFeb 19, 2024High Test Results; High Test Results

  WE RECEIVED AN ALLEGATION OF QUESTIONABLE ISE RESULTS FOR 3 PATIENTS' URINE SAMPLES TESTED ON A COBAS PRO ISE ANALYTICAL UNIT WHEN COMPARED TO A DIFFERENT COBAS PRO ISE ANALYTICAL UNIT. RESULTS FOR THE FOLLOWING TESTS WERE AFFECTED: SODIUM (NA) AND CHLORIDE (CL). SAMPLE 1: NA: INITIAL RESULT: 151 MMOL/L. REPEAT RESULT: 139 MMOL/L (TESTED ON ANOTHER COBAS PRO ISE). SAMPLE 2: NA: INITIAL RESULT: 150 MMOL/L. REPEAT RESULT: 139 MMOL/L (TESTED ON ANOTHER COBAS PRO ISE). SAMPLE 3: NA: INITIAL RESULT: 151 MMOL/L. REPEAT RESULT: 139 MMOL/L (TESTED ON ANOTHER COBAS PRO ISE). CL: INITIAL RESULT: 114 MMOL/L. REPEAT RESULT: 103 MMOL/L (TESTED ON ANOTHER COBAS PRO ISE). DELTA CHECKS ON PATIENT SAMPLES PROMPTED THE REPEAT OF THE SAMPLES. THE REPEAT RESULTS WERE DEEMED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18730658 ↗
• MalfunctionFeb 16, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  WE RECEIVED AN ALLEGATION OF QUESTIONABLE ISE RESULTS FOR AN UNSPECIFIED NUMBER OF PATIENTS' SERUM/PLASMA SAMPLES TESTED ON A COBAS PRO ISE ANALYTICAL UNIT. RESULTS FOR THE SODIUM (NA) TEST WERE AFFECTED. NO DISCREPANT RESULTS WERE PROVIDED. THE REPORTER ALLEGED THAT THE DIFFERENCE BETWEEN THE INITIAL AND THE REPEAT MEASUREMENTS WAS >7 MMOL/L. THE REPORTER ALSO STATED THAT THEY HAD SEEN A SALT BUILD-UP ON THE ULTRASONIC MIXER AND FOR THAT REASON, THE SAMPLES WERE RE-TESTED. THE REPEAT RESULTS WERE DEEMED TO BE CORRECT. REPORTEDLY, AN AMENDED REPORT WITH THE CORRECT RESULTS WAS ISSUED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18719775 ↗
• MalfunctionFeb 15, 2024High Test Results; High Test Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ISE INDIRECT NA AND CI FOR GEN.2 RESULTS FROM MULTIPLE PATIENT SAMPLES TESTED ON THE COBAS PRO ISE ANALYTICAL UNIT. THE INITIAL RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE DOCTORS QUESTIONED THE RESULTS PROMPTING THE RERUN OF THE PATIENT SAMPLES. THE REPORTER WAS ABLE TO PROVIDE ONE PATIENT SAMPLE WITH DISCREPANT RESULTS. THE INITIAL NA RESULT WAS 151.6 MMOL/L. THE REPEAT RESULT WAS 135.0 MMOL/L. THE INITIAL CL RESULT WAS 116.8 MMOL/L. THE REPEAT RESULT WAS 105.6 MMOL/L. THE REPEAT RESULTS WERE DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18710181 ↗
• MalfunctionFeb 14, 2024Low Test Results; Low Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ISE INDIRECT GEN 2 RESULTS FROM THE COBAS PRO ISE ANALYTICAL UNIT. ONE EXAMPLE WAS AN INITIAL RESULT OF 129 MMOL/L AND A REPEAT RESULT OF 136 MMOL/L. THE REPEAT RESULTS WERE BELIEVED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18702717 ↗
• MalfunctionFeb 9, 2024Non Reproducible Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE NA RESULTS FOR 2 PATIENT SAMPLES ON A COBAS PRO ISE MODULE. SAMPLE 1: THE INITIAL RESULT WAS 152 MMOL/L. THE REPEATED RESULT WAS 142 MMOL/L. SAMPLE 2: ON (B)(6) 2024 THE INITIAL RESULT WAS 150 MMOL/L. THE REPEATED RESULT WAS 138 MMOL/L. THE REPEATED RESULTS WERE OBTAINED ON ANOTHER ANALYZER. THE REPEATED RESULTS WERE BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18681532 ↗
• MalfunctionFeb 8, 2024Output Problem; Non Reproducible Results; Output Problem; Non Reproducible Results

  THE INITIAL REPORTER QUESTIONED AN UNSPECIFIED NUMBER OF PATIENT SAMPLES FOR ISE TESTS ON A COBAS PRO ISE ANALYTICAL UNIT COMPARED TO A COBAS PURE ANALYZER. DISCREPANT ISE SODIUM ELECTRODE RESULTS WERE PROVIDED FOR 1 PATIENT SAMPLE. THE INITIAL RESULT FROM THE ISE ANALYZER WAS 116 MMOL/L. THE REPEAT RESULT FROM A COBAS PURE ANALYZER WAS 126 MMOL/L. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. IT IS NOT KNOWN WHICH RESULT WAS BELIEVED TO BE CORRECT. THE CUSTOMER DECLINED TO PROVIDE ANY ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18669719 ↗
• MalfunctionFeb 7, 2024High Test Results; High Test Results

  WE RECEIVED AN ALLEGATION OF QUESTIONABLE ISE RESULTS FOR 1 PATIENT'S SERUM SAMPLE TESTED ON A COBAS PRO ISE ANALYTICAL UNIT WHEN COMPARED TO A DIFFERENT ANALYZER. RESULTS FOR THE FOLLOWING TESTS WERE AFFECTED: SODIUM (NA) AND CHLORIDE (CL). NA: INITIAL RESULT: 152.6 MMOL/L. REPEAT RESULT: 138 MMOL/L (TESTED ON ANOTHER ANALYZER). CL: INITIAL RESULT: 112.7 MMOL/L. REPEAT RESULT: 100.8 MMOL/L (TESTED ON ANOTHER ANALYZER). SINCE THE INITIAL RESULTS DID NOT MATCH THE POINT OF CARE (POC) RESULTS, THE SAMPLES WERE THEN REPEATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18660852 ↗
• MalfunctionFeb 6, 2024Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ISE INDIRECT NA AND K FOR GEN.2 RESULTS FROM ONE PATIENT SAMPLE TESTED ON THE COBAS PRO ISE ANALYTICAL UNIT. THE INITIAL NA RESULT WAS 163.3 MMOL/L. THE FIRST REPEAT RESULT WAS 149.1 MMOL/L. THE SECOND REPEAT RESULT WAS 151.6 MMOL/L. THIS RESULT WAS REPORTED TO THE PATIENT. THE INITIAL K RESULT WAS 4.89 MMOL/L. THE REPEAT RESULT WAS 4.43 MMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18650327 ↗
• MalfunctionFeb 2, 2024Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED A QUESTIONABLE ISE INDIRECT NA FOR GEN.2 RESULT FROM AN UNSPECIFIED NUMBER OF PATIENT SAMPLES TESTED ON THE COBAS PRO ISE ANALYTICAL UNIT. THE INITIAL RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE RESULTS HAD DELTA CHECK FAILURES PROMPTING THE RERUN OF THE PATIENT SAMPLES ON ANOTHER COBAS PRO ISE ANALYTICAL UNIT. THE REPORTER WAS ABLE TO PROVIDE ONE PATIENT SAMPLE WITH DISCREPANT RESULTS: THE INITIAL RESULT FROM THE ANALYZER WAS 147 MMOL/L. THE REPEAT RESULT FROM THE OTHER ANALYZER WAS 134 MMOL/L. THE REPEAT RESULT WAS DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18631586 ↗
• MalfunctionJan 30, 2024High Test Results; No Apparent Adverse Event; High Test Results; No Apparent Adverse Event

  THERE WAS AN ALLEGATION OF QUESTIONABLE GEN.2 ISE INDIRECT FOR NA RESULTS FOR 1 PATIENT SAMPLE ON A COBAS PRO ISE ANALYTICAL UNIT. THE INITIAL NA RESULT WAS 151.6 MMOL/L. THE DOCTOR QUESTIONED THE INITIAL RESULT AND THE SAMPLE WAS REPEATED. THE SAMPLE WAS REPEATED ON ANOTHER PRO ISE ANALYZER AND THE REPEAT RESULT WAS 142 MMOL/L. THE REPEAT RESULT WAS DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18607973 ↗
• MalfunctionJan 26, 2024Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Incorrect, Inadequate or Imprecise Result or Readings; High Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE RESULTS FOR AN UNSPECIFIED NUMBER OF PATIENT SAMPLES TESTED ON THE COBAS PRO ISE ANALYTICAL UNIT. THE CUSTOMER PROVIDED DATA FOR FIVE PATIENT SAMPLES WITH DISCREPANT ISE RESULTS. RESULTS FROM THE FOLLOWING ASSAYS WERE AFFECTED: NA ELECTRODE, K ELECTRODE, CL ELECTRODE. THE CUSTOMER STATED THEY CHANGED THE ELECTRODES EARLY IN THE MORNING. CALIBRATION AND CONTROLS PASSED. LATER IN THE MORNING, THE CUSTOMER STARTED NOTICING HIGH NA RESULTS FOR PATIENT SAMPLES. THE CUSTOMER TRIED RE-CALIBRATING, BUT CALIBRATION WAS NOT SUCCESSFUL. THE CUSTOMER TRIED USING PATIENT SERUM TO ACTIVATE THE ELECTRODES, BUT CALIBRATION WAS STILL FAILING. THE CUSTOMER THEN REPEATED PATIENT SAMPLES ON A SECOND ANALYZER. INITIAL TEST RESULTS: PATIENT SAMPLE 1: NA = 127 MMOL/L, K = 3.6 MMOL/L PATIENT SAMPLE 2: NA = 127 MMOL/L PATIENT SAMPLE 3: NA = 127 MMOL/L PATIENT SAMPLE 4: NA = 129 MMOL/L PATIENT SAMPLE 5: NA = 125 MMOL/L, CL = 94 MMOL/L REPEAT RESULTS: PATIENT SAMPLE 1: NA = 140 MMOL/L, K = 4.03 MMOL/L PATIENT SAMPLE 2: NA = 139 MMOL/L PATIENT SAMPLE 3: NA = 139 MMOL/L PATIENT SAMPLE 4: NA = 141.4 MMOL/L PATIENT SAMPLE 5: NA = 141.7 MMOL/L, CL = 105.9 MMO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18587685 ↗
• MalfunctionJan 23, 2024High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ISE INDIRECT GEN 2 SODIUM RESULTS FROM THE COBAS PRO ISE ANALYTICAL UNIT. ONE EXAMPLE WAS PROVIDED. THE INITIAL RESULT WAS 150 MMOL/L AND WAS REPORTED OUTSIDE OF THE LABORATORY. THE REPEAT RESULT ON ANOTHER COBAS PRO ISE ANALYTICAL UNIT WAS 140 MMOL/L. THE REPEAT RESULTS WERE BELIEVED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18562522 ↗
• MalfunctionJan 22, 2024Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ISE INDIRECT NA FOR GEN.2 RESULTS FROM FOUR PATIENT SAMPLES TESTED ON THE COBAS PRO ISE ANALYTICAL UNIT. THE INITIAL RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. SAMPLE 1 THE INITIAL NA RESULT WAS 149 MMOL/L. THE DOCTOR QUESTIONED THE RESULT PROMPTING THE RERUN OF THE PATIENT SAMPLE. THE REPEAT RESULT WAS 137 MMOL/L. SAMPLE 2 THE INITIAL NA RESULT WAS 150 MMOL/L. THE DOCTOR QUESTIONED THE RESULT PROMPTING THE RERUN OF THE PATIENT SAMPLE. THE REPEAT RESULT WAS 140 MMOL/L. SAMPLE 3 THE INITIAL NA RESULT WAS 149 MMOL/L. THE RESULT FAILED A DELTA CHECK PROMPTING THE RERUN OF THE PATIENT SAMPLE. THE REPEAT RESULT WAS 139 MMOL/L. SAMPLE 4 THE INITIAL NA RESULT WAS 151 MMOL/L. THE RESULT FAILED A DELTA CHECK PROMPTING THE RERUN OF THE PATIENT SAMPLE. THE REPEAT RESULT WAS 140 MMOL/L. THE REPEAT RESULTS WERE DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18551006 ↗
• MalfunctionJan 11, 2024High Test Results; High Test Results

  WE RECEIVED AN ALLEGATION OF QUESTIONABLE ISE RESULTS FOR 1 PATIENT'S PLASMA SAMPLE TESTED ON A COBAS PRO ISE ANALYTICAL UNIT. RESULTS FOR THE POTASSIUM (K) TEST WERE AFFECTED. INITIAL RESULT: 5.96 MMOL/L. THE PHYSICIAN QUESTIONED THE RESULT AND ASKED TO RERUN THE SAMPLE. ON 14-DEC-2023 THE SAMPLE WAS RERUN AND RESULTED IN A VALUE OF 3.95 MMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18495286 ↗
• MalfunctionJan 9, 2024Low Test Results; Low Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE GEN.2 ISE INDIRECT FOR NA RESULTS FOR 1 PATIENT SAMPLE ON A COBAS PRO ISE ANALYTICAL UNIT. THE INITIAL RESULT WAS 130 MMOL/L. THE DOCTOR QUESTIONED THE RESULT AND THE SAMPLE WAS REPEATED. THE SAMPLE WAS REPEATED ON ANOTHER PRO ISE ANALYZER AND THE REPEAT RESULT WAS 138 MMOL/L. THE REPEAT RESULT WAS DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18476444 ↗
• MalfunctionJan 5, 2024Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ISE INDIRECT NA FOR GEN.2 RESULTS FROM AN UNSPECIFIED NUMBER OF PATIENT SAMPLES TESTED ON THE COBAS PRO ISE ANALYTICAL UNIT. THE REPORTER WAS ABLE TO PROVIDE ONE EXAMPLE OF A DISCREPANT RESULT. THE REPORTER NOTED THAT THE INITIAL RESULT DID NOT MATCH THE PATIENT'S HISTORICAL RUNS AND REFERRED IT TO THE DOCTOR WHO AGREED TO RERUN THE PATIENT SAMPLE. THE PATIENT SAMPLE WAS RERUN ON THEIR OTHER COBAS PRO ISE ANALYTICAL UNIT. THE INITIAL RESULT FROM THE ANALYZER WAS 135 MMOL/L. THE REPEAT RESULT FROM THE OTHER ANALYZER WAS 126 MMOL/L. THE REPEAT RESULT WAS DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18454397 ↗