Sodium Electrode 21029371001Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 04015630032457), received between Oct 14, 2022 and Jun 23, 2025 — classified as 25 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (15 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 25 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 23, 2025High Test Results; Output Problem; High Test Results; Output Problem

  THERE WAS AN ALLEGATION OF QUESTIONABLE ISE SODIUM ELECTRODE RESULTS FOR 1 PATIENT SAMPLE ON A COBAS PRO ISE ANALYTICAL UNIT. THE INITIAL RESULT WAS 148 MMOL/L. THE REPEATED RESULT WAS 140 MMOL/L. THE SAMPLE WAS REPEATED BECAUSE THE INITIAL RESULT DID NOT MATCH THE PATIENT'S CLINICAL PICTURE. THE REPEATED RESULT WAS OBTAINED ON ANOTHER MODULE AND WAS BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22310072 ↗
• 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 ISE SODIUM ELECTRODE. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE CHLORIDE 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 22013130 ↗
• MalfunctionMar 12, 2025Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE NA ELECTRODE ASSAY RESULTS FROM MULTIPLE PATIENT SAMPLES TESTED ON THE COBAS INTEGRA 400 PLUS. THE FOLLOWING ARE EXAMPLES OF DISCREPANT RESULTS FROM THE ANALYZER: SAMPLE 1 THE INITIAL NA RESULT WAS 132 MMOL/L. THE REPEAT RESULT WAS 139 MMOL/L. SAMPLE 2 THE INITIAL NA RESULT WAS 132 MMOL/L. THE REPEAT RESULT WAS 138 MMOL/L. SAMPLE 3 THE INITIAL NA RESULT WAS 134 MMOL/L. THE REPEAT RESULT WAS 140 MMOL/L. THE INITIAL RESULTS WERE BELOW THE REFERENCE RANGE, PROMPTING THE PATIENT SAMPLE RERUNS. THE REPEAT RESULTS WERE DEEMED CORRECT. THE REPORTER STATED THEY ALSO RECEIVED ION-SELECTIVE ELECTRODE (ISE) UNSTABLE AND SOLUTION ERRORS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21582990 ↗
• MalfunctionAug 26, 2024Low Test Results; Low Test Results

  THE INITIAL REPORTER COMPLAINED OF LOW RESULTS FOR AN UNSPECIFIED NUMBER OF PATENT SAMPLES TESTED FOR SODIUM ELECTRODE (NA) ON A COBAS INTEGRA 400 PLUS ANALYZER. AN EXAMPLE OF DISCREPANT RESULTS WAS PROVIDED FOR 1 PATIENT SAMPLE. THE RESULT FROM THE INTEGRA 400 PLUS ANALYZER WAS 133 MMOL/L. THE RESULT FROM THE CUSTOMER'S COBAS 6000 SYSTEM WAS 140 MMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20069122 ↗
• MalfunctionJul 1, 2024Low Test Results; Low Test Results

  WE RECEIVED AN ALLEGATION OF QUESTIONABLE ISE RESULTS FOR 2 PATIENTS' SERUM SAMPLES TESTED ON A COBAS INTEGRA 400 PLUS ANALYZER. RESULTS FOR THE SODIUM (NA) TEST WERE AFFECTED. SAMPLE 1 (PATIENT 1): INITIAL RESULT: 129.2 MMOL/L. REPEAT RESULT: 136.9 MMOL/L. SAMPLE 2 (PATIENT 2): INITIAL RESULT: 134.3 MMOL/L. REPEAT RESULT: 143.3 MMOL/L. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE THE LABORATORY AS THE CUSTOMER NOTICED THAT THE NA RESULTS WERE RUNNING LOW. THE SAMPLES WERE THEN REPEATED AND THE REPEAT RESULTS WERE DEEMED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19645463 ↗
• MalfunctionMay 3, 2024Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results; Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results

  WE RECEIVED AN ALLEGATION OF QUESTIONABLE ISE RESULTS FOR 3 PATIENTS' PLASMA SAMPLES TESTED ON A COBAS INTEGRA 400 PLUS ANALYZER. RESULTS FOR THE SODIUM (NA) TEST WERE AFFECTED. SAMPLE 1: INITIAL RESULT: 128 MMOL/L (ACCOMPANIED BY A DATA FLAG). REPEAT RESULT: 140 MMOL/L. SAMPLE 2: INITIAL RESULT: 117 MMOL/L (ACCOMPANIED BY A DATA FLAG). REPEAT RESULT: 139 MMOL/L. SAMPLE 3: INITIAL RESULT: 124 MMOL/L (ACCOMPANIED BY A DATA FLAG). REPEAT RESULT: 138 MMOL/L. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE FIELD DISPATCH FOR ISE CALIBRATION ERRORS PROMPTED THE REPEAT OF THE SAMPLE. THE REPEAT RESULTS WERE DEEMED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19241828 ↗
• MalfunctionMar 6, 2024Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem

  THERE WAS AN ALLEGATION OF QUESTIONABLE ISE INDIRECT GEN 2 SODIUM RESULTS FROM THE COBAS 6000 C 501 ANALYZER. THE INITIAL RESULT WAS 160 MMOL/L AND THE REPEAT RESULT ON THE SAME ANALYZER WAS 135 MMOL/L. THE SAMPLE WAS REPEATED ON AN INTEGRA 400 ANALYZER AND THE RESULT WAS 134 MMOL/L. THE REPEAT RESULT WAS BELIEVED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18851597 ↗
• MalfunctionJan 24, 2024Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Incorrect, Inadequate or Imprecise Result or Readings; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ISE INDIRECT GEN 2 SODIUM RESULTS FROM THE COBAS 6000 C 501 MODULE. REFER TO THE ATTACHMENT TO THE MEDWATCH FOR ALL PATIENT DATA. THE CUSTOMER STATED SOME OF THE REPORTED RESULTS WERE UPDATED BUT OTHERS WERE NOT UPDATED AFTER REPEAT TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18570683 ↗
• 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 NA. REFER TO MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6), FOR INFORMATION ON THE CL 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 18172802 ↗
• MalfunctionNov 6, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR UNSPECIFIED PATIENTS' SAMPLES TESTED WITH SODIUM (NA) ASSAY ON A COBAS INTEGRA 400 PLUS ANALYZER COMPARED TO TESTING WITH THE OLD NA ELECTRODE THAT WAS PREVIOUSLY IN USE. ONLY 1 PATIENT'S SAMPLE WAS RE-TESTED AND PROVIDED AFTER THE ELECTRODE REPLACEMENT. AT 08:56 A.M. THE SAMPLE WAS TESTED MULTIPLE TIMES ON A DIFFERENT COBAS INTEGRA 400 PLUS ANALYZER RESULTING IN NA VALUES OF 139.0 MMOL/L, 139.2 MMOL/L, 138.6 MMOL/L, 138.6 MMOL/L, 138.7 MMOL/L, 138.6 MMOL/L, 139.8 MMOL/L, 138.7 MMOL/L, 138.1 MMOL/L. AT 10:41 A.M. THE SAMPLE WAS TESTED MULTIPLE TIMES AND THE RESULTS WERE: 125.5 MMOL/L, 126.1 MMOL/L, 127.1 MMOL/L, 126.8 MMOL/L, AND 125.7 MMOL/L. THE OLD ELECTRODE WAS RE-INSTALLED AND THE SAMPLE WAS THEN REPEATED MULTIPLE TIMES. AT 11:54 A.M. THE REPEAT RESULTS WERE: 141.5 MMOL/L, 139.3 MMOL/L, 140.1 MMOL/L, 139.9 MMOL/L, AND 141.8 MMOL/L. THE RESULT RELEASED TO THE PATIENT AND THE PHYSICIAN WAS 139.0 MMOL/L OBTAINED FROM THE OTHER COBAS INTEGRA 400 PLUS SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18072550 ↗
• MalfunctionAug 25, 2023Output Problem; Output Problem

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ISE INDIRECT NA FOR GEN.2 RESULTS FROM THREE PATIENT SAMPLES TESTED ON THE COBAS INTEGRA 400 PLUS. THE INITIAL RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THE PATIENT SAMPLES WERE RERUN ON THEIR OTHER ANALYZER. SAMPLE 1: THE INITIAL RESULT WAS FROM THE ANALYZER 168.2 MMOL/L. THE REPEAT RESULT FROM THE OTHER ANALYZER WAS 139.0 MMOL/L. SAMPLE 2: THE INITIAL RESULT FROM THE ANALYZER WAS 174.8 MMOL/L. THE REPEAT RESULT FROM THE OTHER ANALYZER WAS 139.0 MMOL/L. SAMPLE 3: THE INITIAL RESULT FROM THE ANALYZER WAS 158.8 MMOL/L. THE REPEAT RESULT FROM THE OTHER ANALYZER WAS 139.0 MMOL/L..

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17625727 ↗
• MalfunctionJul 19, 2023Low 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 INTEGRA 400 PLUS MODULE. THE INITIAL NA RESULT FROM INTEGRA ANALYZER SERIAL NUMBER (B)(6) WAS 133 MMOL/L. THE SAMPLE WAS REPEATED ON ANOTHER INTEGRA ANALYZER WAS 127 MMOL/L. THE SAMPLE WAS REPEATED ON A ANOTHER ANALYZER DUE TO ONGOING ISE ISSUES WITH THAT ANALYZER. THE INITIAL RESULT OF 133 MMOL/L WAS DEEMED CORRECT. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17356443 ↗
• MalfunctionJul 17, 2023Low Test Results; Low Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE GEN.2 ISE INDIRECT FOR NA RESULTS FOR 10 PATIENT SAMPLES ON A COBAS E 411 IMMUNOASSAY ANALYZER. THE CUSTOMER WAS HAVING CALIBRATION ISSUES WITH THE NA ELECTRODE AND REPLACED IT BEFORE REPEATING THE SAMPLES. FOR PATIENT 1, THE INITIAL NA RESULT WAS 134 MMOL/L. THE REPEAT RESULT WAS 139.28 MMOL/L. FOR PATIENT 2, THE INITIAL NA RESULT WAS 133 MMOL/L. THE REPEAT RESULT WAS 141 MMOL/L. FOR PATIENT 3, THE INITIAL NA RESULT WAS 120 MMOL/L. THE REPEAT RESULT WAS 135 MMOL/L. FOR PATIENT 4, THE INITIAL NA RESULT WAS 130 MMOL/L. THE REPEAT RESULT WAS 136 MMOL/L. FOR PATIENT 5, THE INITIAL NA RESULT WAS 133 MMOL/L. THE REPEAT RESULT WAS 140 MMOL/L. FOR PATIENT 6, THE INITIAL NA RESULT WAS 134 MMOL/L. THE REPEAT RESULT WAS 141 MMOL/L. FOR PATIENT 7, THE INITIAL NA RESULT WAS 135 MMOL/L. THE REPEAT RESULT WAS 143 MMOL/L. FOR PATIENT 8, THE INITIAL NA RESULT WAS 134 MMOL/L. THE REPEAT RESULT WAS 141 MMOL/L. FOR PATIENT 9, THE INITIAL NA RESULT WAS 133 MMOL/L. THE REPEAT RESULT WAS 141 MMOL/L. FOR PATIENT 10, THE INITIAL NA RESULT WAS 134 MMOL/L. THE REPEAT RESULT WAS 140 MMOL/L. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE REPEAT RES

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17335329 ↗
• MalfunctionJul 13, 2023Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results; Incorrect, Inadequate or Imprecise Result or Readings; 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 6000 C (501) MODULE. THE INITIAL RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE REPORTER STATED THE SODIUM PATIENT RESULTS WERE LOW AND THAT SOME DOCTORS QUESTIONED THE RESULTS WHICH PROMPTED THE RERUN OF THE PATIENT SAMPLES. THEY STATED THAT QC WAS WITHIN RANGE BUT ABOUT -1 STANDARD DEVIATION. THE DIFFERENCE BETWEEN THE INITIAL AND REPEAT RESULTS WAS REPORTEDLY 7 TO 8 MMOL/L WITH ONE RESULT DIFFERENCE AS HIGH AS 10 MMOL/L. THE REPORTER STATED THEY HAD TO ISSUE 32 CORRECTED REPORTS. THE REPORTER WAS ABLE TO PROVIDE ONE EXAMPLE OF A DISCREPANT RESULT. THE REPORTER STATED THAT THE REPEAT RESULT MAY HAVE BEEN FROM THEIR OTHER ANALYZER. THE INITIAL SODIUM RESULT FROM THE MODULE WAS 126 MMOL/L. THE REPEAT RESULT WHICH MAY HAVE BEEN FROM THEIR OTHER ANALYZER WAS 134 MMOL/L. THE REPEAT RESULT WAS DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17316901 ↗
• MalfunctionApr 13, 2023Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH NA (SODIUM) ON A COBAS INTEGRA 400 PLUS ANALYZER. THE SAMPLE INITIALLY RESULTED IN A NA VALUE OF 126.5 MMOL/L AND REPEATED AS 138.9 MMOL/L. THE REPEAT RESULT WAS DEEMED CORRECT. THE INITIAL QUESTIONABLE RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE NA ELECTRODE LOT NUMBER AND EXPIRATION DATE WERE REQUESTED BUT NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16733840 ↗
• MalfunctionMar 17, 2023Low Test Results; Low Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH THE NA+ ELECTRODE ON A COBAS INTEGRA 400 PLUS (SERIAL NUMBER (B)(4)). THE SAMPLE INITIALLY RESULTED IN A NA VALUE OF 130 MMOL/L AND REPEATED AS 131 MMOL/L ON THE INTEGRA 400 PLUS ANALYZER. THE INITIAL VALUE WAS REPORTED OUTSIDE OF THE LABORATORY AND QUESTIONED BY A DOCTOR. THE SAMPLE WAS SENT TO ANOTHER FACILITY AND TESTED ON AN UNKNOWN ANALYZER, RESULTING IN A VALUE OF 137 MMOL/L. THE REPEAT VALUE OF 137 MMOL/L WAS DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16566976 ↗
• MalfunctionDec 20, 2022Mechanical Problem; Low Test Results; Insufficient Device Problem Information; Mechanical Problem; Low Test Results; Insufficient Device Problem Information

  THERE WAS AN ALLEGATION OF QUESTIONABLE ISE INDIRECT GEN 2 SODIUM RESULTS FOR QC AND PATIENT SAMPLES FROM COBAS INTEGRA 400 PLUS ANALYZER SERIAL NUMBER 421575. THE INITIAL RESULT WAS 129.9 MMOL/L AND THE REPEAT RESULT WAS 136.2 MMOL/L. THE QUESTIONABLE RESULT WAS REPORTED OUTSIDE OF THE LABORATORY AND WAS CORRECTED WITH THE REPEAT RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16014176 ↗
• MalfunctionDec 12, 2022Low Test Results; Low Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE GEN.2 ISE INDIRECT FOR NA RESULTS FOR 3 PATIENT SAMPLES ON A COBAS INTEGRA 400 PLUS MODULE. THE CUSTOMER WAS PROMPTED TO RERUN PATIENT SAMPLES DUE TO QC AND CALIBRATION FAILURES FROM A NEW NA ELECTRODE. FOR PATIENT 1, THE INITIAL NA RESULT WAS 124 MMOL/L. THE REPEAT RESULT WAS 131 MMOL/L. THE INITIAL RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE REPEAT RESULT WAS DEEMED CORRECT. ON (B)(6) 2022, THE INITIAL NA RESULTS FOR PATIENT 2 WERE 129.3 MMOL/L AND 129.3 MMOL/L. ON (B)(6) 2022, THE REPEAT RESULTS WERE 134.4 MMOL/L, 134.6 MMOL/L, AND 133.9 MMOL/L. ON (B)(6) 2022, THE INITIAL NA RESULTS FOR PATIENT 3 WERE 130.3 MMOL/L, 128.0 MMOL/L, AND 129.0 MMOL/L. ON (B)(6) 2022, THE REPEAT RESULT WAS 134.6 MMOL/L. IT IS UNKNOWN IF THE INITIAL RESULTS FOR PATIENTS 2 AND 3 WERE REPORTED OUTSIDE OF THE LABORATORY. THE NA ELECTRODE LOT NUMBER AND EXPIRATION DATE WERE REQUESTED BUT NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15959760 ↗
• MalfunctionDec 9, 2022Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE GEN.2 ISE INDIRECT FOR NA RESULTS FOR 1 PATIENT SAMPLE ON A COBAS INTEGRA 400 PLUS MODULE. THE INITIAL NA RESULT WAS 129.9 MMOL/L. THE RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE CUSTOMER WAS HAVING ISSUES WITH OUT-OF-RANGE QC AND REPEATED THE SAMPLE ON ANOTHER 400-PLUS ANALYZER. THE REPEAT RESULT ON ANOTHER ANALYZER WAS 136.2 MMOL/L. THE REPEAT RESULT WAS DEEMED CORRECT. THE INTEGRA 400 PLUS ANALYZER SERIAL NUMBER IS (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15949044 ↗
• MalfunctionDec 5, 2022Non Reproducible Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE GEN.2 ISE INDIRECT FOR NA RESULTS FOR 1 PATIENT SAMPLE ON A COBAS INTEGRA 400 PLUS MODULE. THE INITIAL NA RESULT WAS 105 MMOL/L. THE SAMPLE WAS REPEATED ON ANOTHER INTEGRA MODULE AND THE RESULT WAS 120 MMOL/L. THE INITIAL RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THE NA ELECTRODE LOT NUMBER AND EXPIRATION DATE WERE REQUESTED BUT NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15920745 ↗
• MalfunctionNov 10, 2022Low Test Results; Low Test Results

  THERE WAS AN ALLEGATION OF CALIBRATION ERRORS AND QUESTIONABLE ISE INDIRECT GEN 2 RESULTS FROM THE COBAS INTEGRA 400+ ANALYZER. THE QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY AND THE PHYSICIANS QUESTIONED THEM, AS THE RESULTS DID NOT MATCH THE CLINICAL CONDITION OF NORMAL AMBULATORY PATIENTS. THE CUSTOMER SENT THE SAMPLES TO ANOTHER LABORATORY THAT USED AN ABBOTT ARCHITECT, AND THE RESULTS WERE ALL WITHIN THE NORMAL REFERENCE RANGE. THESE RESULTS WERE DEEMED CORRECT. ONE EXAMPLE WAS PROVIDED OF AN INITIAL SODIUM RESULT OF 132 MMOL/L AND A REPEAT RESULT OF 138 MMOL/L. THE ELECTRODE LOT NUMBER AND EXPIRATION DATE WERE REQUESTED BUT WERE NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15770125 ↗
• MalfunctionNov 10, 2022Incorrect Measurement; Non Reproducible Results; Incorrect Measurement; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR THREE PATIENT SAMPLES TESTED WITH THE NA+ ELECTRODE ON A COBAS INTEGRA 400 PLUS. NO INCORRECT RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE FIRST SAMPLE INITIALLY RESULTED IN A NA VALUE OF 126 MMOL/L AND REPEATED WITH A VALUE OF 132 MMOL/L. THE SECOND SAMPLE INITIALLY RESULTED IN A NA VALUE OF 118 MMOL/L AND REPEATED WITH A VALUE OF 138 MMOL/L. THE THIRD SAMPLE INITIALLY RESULTED IN A NA VALUE OF 120 MMOL/L AND REPEATED WITH A VALUE OF 140 MMOL/L. THE NA ELECTRODE LOT NUMBER AND EXPIRATION DATE WERE REQUESTED, BUT NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15770121 ↗
• MalfunctionOct 20, 2022Low Test Results; Low Test Results

  THE INITIAL REPORTER STATED THEY HAVE BEEN HAVING ISSUES WITH ISE TESTS ON THE COBAS INTEGRA 400 PLUS. THEY HAVE BEEN RECEIVING ISE UNSTABLE FLAGS FOR CALIBRATION AND CONTROL SAMPLES THROUGHOUT THE DAY. THEY ALSO HAD ISSUES WITH NA+ ELECTRODE CALIBRATION OVER THE PAST FEW DAYS. THE CUSTOMER TRIED REPLACING THE NA ELECTRODE, ELECTRODE O-RINGS, AND SYSTEM REAGENTS. THE CUSTOMER ALSO ROLLED THE PERISTALTIC PUMP TUBING, CLEANED THE REFERENCE TUBING OF SALT BUILDUP AT THE TOP OF THE SYSTEM REAGENT BOTTLE, AND RAN CLEANING MAINTENANCE. THE CUSTOMER PRIMED, ACTIVATED, AND INITIALIZED THE ISE TEST SEVERAL TIMES. THE CUSTOMER REPLACED THE MIX TOWER DUE TO A PRIMING ERROR AND RAN A NEW CALIBRATION THAT FAILED. DURING THE ISSUE, THE CUSTOMER NOTED THEY RECEIVED DISCREPANT NA RESULTS FOR FOUR PATIENT SAMPLES. NO INCORRECT RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE FIRST PATIENT SAMPLE INITIALLY RESULTED IN A NA VALUE OF 133.59 MMOL/L, WHICH REPEATED AS 142.37 MMOL/L. THE REPEAT VALUE WAS DEEMED CORRECT. THE SECOND PATIENT SAMPLE INITIALLY RESULTED IN A NA VALUE OF 129.23 MMOL/L, WHICH REPEATED AS 138.03 MMOL/L. THE REPEAT VALUE WAS DEEMED CORRECT. THE THIRD PATIENT SAMPLE INITIALLY R

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15644287 ↗
• MalfunctionOct 20, 2022Low Test Results; Low Test Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE GEN.2 ISE INDIRECT FOR NA RESULTS FOR 11 PATIENT SAMPLES TESTED ON AN INTEGRA 400 PLUS MODULE. THE CUSTOMER PROVIDED 3 EXAMPLES OF DISCREPANT RESULTS FROM 3 PATIENT SAMPLES TESTED. THE INITIAL RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE REPORTER RECEIVED A CALL QUESTIONING THE LOW RESULTS AND THEY REPEATED THE SAMPLES. FOR SAMPLE ID (B)(6), THE INITIAL NA RESULT WAS 123 MMOL/L. THE REPEAT RESULT WAS 143 MMOL/L. FOR SAMPLE ID (B)(6), THE INITIAL NA RESULT WAS 125 MMOL/L. THE REPEAT RESULT WAS 141 MMOL/L. FOR SAMPLE ID (B)(6), THE INITIAL NA RESULT WAS 122 MMOL/L. THE REPEAT RESULT WAS 139 MMOL/L. THE REPEAT RESULTS WERE DEEMED CORRECT. THE ELECTRODE SERIAL NUMBER AND EXPIRATION DATE WERE REQUESTED BUT NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15638107 ↗
• MalfunctionOct 14, 2022Incorrect, 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 NA+ ELECTRODE ON COBAS INTEGRA 400 PLUS SERIAL NUMBER (B)(4). NO INCORRECT RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE REPORTER ALSO NOTED THEY HAD BEEN RECEIVING ISE SENSOR ALARMS FOR SEVERAL DAYS. CALIBRATION ALARMS WERE ALSO RECEIVED. THE PATIENT SAMPLE INITIALLY RESULTED IN A NA VALUE OF 128.7 MMOL/L. THE SAMPLE WAS REPEATED THREE ADDITIONAL TIMES, RESULTING IN VALUES OF 131.8 MMOL/L, 132.8 MMOL/L, AND 125.3 MMOL/L. THE CUSTOMER DID NOT KNOW WHICH RESULT WAS CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15608655 ↗