cobas 8000 cobas ISE module 05964075001Recalls & reported problems

Summary

The FDA's MAUDE database contains 419 adverse event reports that list this exact device (DI 04015630946341), received between Jul 16, 2018 and Jan 24, 2025 — classified as 2 injuries, 417 malfunctions.

The most frequently reported specific device problem is “Non Reproducible Results” (186 reports).

11 other recalls cover devices cleared under the same FDA submission (K100853); 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. 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 419 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 24, 2025Non Reproducible Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE NA ELECTRODE (SODIUM) AND CL ELECTRODE (CHLORIDE) RESULTS FOR 1 PATIENT SAMPLE FROM THE COBAS 8000 COBAS ISE MODULE (DOUBLE). THE INITIAL SODIUM RESULT WAS 130 MMOL/L, AND THE REPEAT RESULT WAS 143 MMOL/L. THE INITIAL CHLORIDE RESULT WAS 123 MMOL/L, AND THE REPEAT RESULT WAS 107 MMOL/L. NONE OF THE QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LAB. THE REPEAT RESULTS ARE DEEMED TO BE CORRECT. THE QUESTIONABLE RESULTS WERE REPEATED DUE TO NEGATIVE ANION GAPS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21230588 ↗
• MalfunctionApr 24, 2024Incorrect Measurement; Low Test Results; Incorrect Measurement; Low Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE RESULTS FOR QC AND PATIENT SAMPLES FROM THE COBAS 8000 COBAS ISE MODULE. SAMPLE 1 INITIAL SODIUM RESULT WAS 127 MMOL/L AND THE REPEAT RESULT WAS 138 MMOL/L. SAMPLE 2 INITIAL SODIUM RESULT WAS 125 MMOL/L AND THE REPEAT RESULT WAS 136 MMOL/L. THE INITIAL CHLORIDE RESULT WAS 125 MMOL/L AND THE REPEAT RESULT WAS 97 MMOL/L. THE REPEAT RESULTS WERE BELIEVED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19174514 ↗
• MalfunctionMar 1, 2024Incorrect, Inadequate or Imprecise Result or Readings; Non Reproducible Results; Incorrect, Inadequate or Imprecise Result or Readings; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY IDENTIFIED PERFORMANCE ISSUES WITH ISE RESULTS ON THE COBAS 8000 ISE MODULE BASED ON QUALITY CONTROLS RUN AFTER PATIENT TESTING. PATIENT SAMPLES WERE REPEATED AND APPROXIMATELY 40 PATIENT RESULTS WERE AMENDED. THE CUSTOMER PROVIDED AN EXAMPLE OF ONE PATIENT SAMPLE WITH DISCREPANT NA ELECTRODE RESULTS. THE SAMPLE INITIALLY RESULTED IN A NA VALUE OF 129 MMOL/L. THE SAMPLE WAS REPEATED, RESULTING IN A VALUE OF 141 MMOL/L. THE REPEAT VALUE WAS CONSIDERED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18818732 ↗
• MalfunctionFeb 29, 2024Signal Artifact/Noise; Non Reproducible Results; Signal Artifact/Noise; Non Reproducible Results

  WE RECEIVED AN ALLEGATION OF QUESTIONABLE ISE RESULTS FOR 1 PATIENT SAMPLE TESTED ON A COBAS 8000 COBAS ISE MODULE. RESULTS FOR THE SODIUM (NA) TEST WERE AFFECTED. INITIAL RESULT: 153 MMOL/L. 1ST REPEAT RESULT: 145 MMOL/L. 2ND REPEAT RESULT: 145 MMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18807804 ↗
• MalfunctionFeb 28, 2024Pumping Problem; Non Reproducible Results; Pumping Problem; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE NA+ RESULTS FOR "SEVERAL" PATIENT SAMPLES ON A COBAS 8000 ISE 1800 MODULE. DISCREPANT RESULTS WERE PROVIDED FOR 1 PATIENT SAMPLE. THE INITIAL RESULT WAS 134.28 MMOL/L. THE SAMPLE WAS REPEATED DUE TO THE RESULT NOT MATCHING THE CLINICAL PICTURE OF THE PATIENT. THE REPEATED RESULT WAS 140.67 MMOL/L. THE REPEATED 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 18803315 ↗
• MalfunctionFeb 28, 2024Suction Problem; Non Reproducible Results; Suction Problem; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE NA+ RESULTS FOR "SEVERAL" PATIENT SAMPLES ON A COBAS 8000 ISE 1800 MODULE. AN EXAMPLE OF DISCREPANT RESULTS WAS PROVIDED FOR 1 PATIENT SAMPLE. THE INITIAL RESULT WAS 132.44 MMOL/L. THE SAMPLE WAS REPEATED DUE TO THE RESULT NOT MATCHING THE CLINICAL PICTURE OF THE PATIENT. THE REPEATED RESULT WAS 138.35 MMOL/L. THE REPEATED 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 18803307 ↗
• MalfunctionFeb 21, 2024Non Reproducible Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE INDIRECT GEN 2 SODIUM AND INDIRECT GEN 2 POTASSIUM RESULTS FOR 1 PATIENT ON A COBAS 8000 COBAS ISE MODULE (DOUBLE). THE INITIAL NA RESULT WAS LOWER THAN 80 MMOL/L AND THE REPEAT NA RESULT WAS HIGHER THAN 140 MMOL/L. THE INITIAL POTASSIUM RESULT WAS 1.6 MMOL/L AND THE REPEAT POTASSIUM RESULT WAS HIGHER THAN 3.5 MMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18747928 ↗
• MalfunctionFeb 19, 2024Incorrect, Inadequate or Imprecise Result or Readings; Failure to Calibrate; High Test Results; Incorrect, Inadequate or Imprecise Result or Readings; Failure to Calibrate; High Test Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ISE INDIRECT NA, K, AND CI FOR GEN.2 RESULTS FROM ONE PATIENT SAMPLE TESTED ON THE COBAS 8000 COBAS ISE MODULE (DOUBLE). THE REPORTER STATED THEY ALSO HAD ION-SELECTIVE ELECTRODE (ISE) VOLTAGE ERRORS IN THE ISE CALIBRATIONS. THE INITIAL RESULTS FROM ISE 1 WERE REPORTED OUTSIDE THE LABORATORY. THE ANION GAP CALCULATION WAS QUESTIONED PROMPTING THE RERUN OF THE PATIENT SAMPLE ON THE MODULE'S ISE 2. THE INITIAL NA RESULT FROM ISE 1 WAS 160 MMOL/L. THE REPEAT RESULT FROM ISE 2 WAS 139 MMOL/L. THE INITIAL K RESULT FROM ISE 1 WAS 5.7 MMOL/L. THE REPEAT RESULT FROM ISE 2 WAS 4.3 MMOL/L. THE INITIAL CL FROM ISE 1 RESULT WAS 86 MMOL/L. THE REPEAT RESULT FROM ISE 2 WAS 102 MMOL/L. THE REPEAT RESULTS WERE DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18731634 ↗
• MalfunctionFeb 14, 2024High Test Results; High Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR TWO PATIENT SAMPLES TESTED WITH THE K ELECTRODE ON A COBAS 8000 ISE MODULE. THE CUSTOMER NOTICED THE PATIENT RESULTS DID NOT AGREE WITH THE PATIENTS' HISTORY, SO THEY WERE REPEATED ON THE SECOND CHANNEL OF THE ANALYZER. THE REPEAT RESULTS WERE DEEMED CORRECT AND CORRECTED REPORTS WERE ISSUED. THE FIRST SAMPLE INITIALLY RESULTED IN A K VALUE OF 6.5 MMOL/L AND IT REPEATED AS 4.5 MMOL/L. THE SECOND SAMPLE INITIALLY RESULTED IN A K VALUE OF 2.5 MMOL/L AND IT REPEATED AS 4.2 MMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18704767 ↗
• MalfunctionFeb 9, 2024Non Reproducible Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE NA ELECTRODE RESULTS FOR 10 PATIENT SAMPLES ON A COBAS 8000 ISE 1800 MODULE. SAMPLE 1 (ID: (B)(6)) THE INITIAL RESULT WAS 134 MMOL/L AND THE REPEATED RESULT WAS 141 MMOL/L. THE SAMPLE WAS REPEATED ON ANOTHER ANALYZER AND THE RESULTS WERE 144 MMOL/L AND 140 MMOL/L. THE RESULT OF 140 MMOL/L WAS CONSIDERED TO BE CORRECT. SAMPLE 2 (ID: (B)(6)) THE INITIAL RESULT WAS 135 MMOL/L AND THE REPEATED RESULT WAS 141 MMOL/L. THE SAMPLE WAS REPEATED ON ANOTHER ANALYZER AND THE RESULTS WERE 146 MMOL/L AND 141 MMOL/L. SAMPLE 3 (ID: (B)(6)) THE INITIAL RESULT WAS 133 MMOL/L AND THE REPEATED RESULT WAS 140 MMOL/L. THE SAMPLE WAS REPEATED ON ANOTHER ANALYZER AND THE RESULTS WERE 143 MMOL/L AND 140 MMOL/L. SAMPLE 4 (ID: (B)(6)) THE INITIAL RESULT WAS 134 MMOL/L AND THE REPEATED RESULT WAS 142 MMOL/L. THE SAMPLE WAS REPEATED ON ANOTHER ANALYZER AND THE RESULTS WERE 146 MMOL/L AND 142 MMOL/L. SAMPLE 5 (ID: (B)(6)) THE INITIAL RESULT WAS 135 MMOL/L AND THE REPEATED RESULT WAS 141 MMOL/L. THE SAMPLE WAS REPEATED ON ANOTHER ANALYZER AND THE RESULTS WERE 146 MMOL/L AND 141 MMOL/L. SAMPLE 6 (ID: (B)(6) ) THE INITIAL RESULT WAS 128 MMOL/L AND THE REPEATED RESULT WAS 138

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18678074 ↗
• MalfunctionFeb 8, 2024Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED FOR ISE SODIUM ELECTRODE ON A COBAS 8000 ISE 1800 MODULE. THE INITIAL RESULT WAS 130 MMOL/L. THE SAMPLE WAS REPEATED 4 TIMES WITH RESULTS OF 134 MMOL/L, 137 MMOL/L, 137 MMOL/L, AND 135 MMOL/L. THE CUSTOMER REPEATED THE SAMPLE AS THE INITIAL RESULT DID NOT CORRESPOND TO THE PATIENT¿S HISTORY. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18671136 ↗
• MalfunctionFeb 8, 2024Use of Device Problem; Non Reproducible Results; Use of Device Problem; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ISE INDIRECT NA FOR GEN.2 RESULTS FROM 25 PATIENT SAMPLES TESTED ON THE COBAS 8000 COBAS ISE MODULE (DOUBLE). THE INITIAL RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE REPORTER STATED THE ION-SELECTIVE ELECTRODE (ISE) 1'S INTERNAL QC AND PATIENT RESULT PERFORMANCE DROPPED; THE ISES HAD TO BE RECALIBRATED AND PATIENT RESULTS AMENDED. THE REPORTER WAS ABLE TO PROVIDE THE FOLLOWING PATIENT SAMPLES WITH DISCREPANT RESULTS: SAMPLE ID: (B)(6). THE INITIAL NA RESULT WAS 131 MMOL/L. THE REPEAT RESULT WAS 137 MMOL/L. SAMPLE ID: (B)(6). THE INITIAL NA RESULT WAS 132 MMOL/L. THE REPEAT RESULT WAS 141 MMOL/L. SAMPLE ID: (B)(6). THE INITIAL NA RESULT WAS 133 MMOL/L. THE REPEAT RESULT WAS 139 MMOL/L. SAMPLE ID: (B)(6). THE INITIAL NA RESULT WAS 131 MMOL/L. THE REPEAT RESULT WAS 141 MMOL/L. SAMPLE ID: (B)(6). THE INITIAL NA RESULT WAS 132 MMOL/L. THE REPEAT RESULT WAS 140 MMOL/L. SAMPLE ID: (B)(6). THE INITIAL NA RESULT WAS 126 MMOL/L. THE REPEAT RESULT WAS 135 MMOL/L. SAMPLE ID: (B)(6). THE INITIAL NA RESULT WAS 132 MMOL/L. THE REPEAT RESULT WAS 138 MMOL/L. SAMPLE ID: (B)(6). THE INITIAL NA RESULT WAS 136 MMOL/L. THE REPEAT RESULT WAS 149 MMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18668088 ↗
• MalfunctionFeb 8, 2024Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR TWO PATIENT SAMPLES TESTED WITH THE NA ELECTRODE ON A COBAS 8000 ISE MODULE. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE WAS REPEATED ON THE SAME ANALYZER OR A DIFFERENT ANALYZER AT THE SITE. IT IS NOT KNOWN WHICH ANALYZER WAS USED FOR REPEAT TESTING. THE INITIAL VALUES WERE BELOW THE ASSAY REFERENCE RANGE AND THE REPEAT VALUES WERE WITHIN THE REFERENCE RANGE. THE FIRST SAMPLE INITIALLY RESULTED IN A NA VALUE OF 131.7 MMOL/L. THE SAMPLE WAS REPEATED, RESULTING IN A VALUE OF 138.4 MMOL/L. THE SECOND SAMPLE INITIALLY RESULTED IN A NA VALUE OF 131.6 MMOL/L. THE SAMPLE WAS REPEATED, RESULTING IN A VALUE OF 137.3 MMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18668081 ↗
• MalfunctionFeb 7, 2024Low Test Results; Low Test Results

  WE RECEIVED AN ALLEGATION OF QUESTIONABLE ISE RESULTS FOR 5 PATIENTS' PLASMA SAMPLES TESTED ON A COBAS 8000 COBAS ISE MODULE (ISE-2 LINE 2) WHEN COMPARED TO A DIFFERENT COBAS 8000 COBAS ISE MODULE (LINE 1). RESULTS FOR THE SODIUM (NA) TEST WERE AFFECTED. SAMPLE 1 (PATIENT 1): INITIAL RESULT: 129 MMOL/L. REPEAT RESULT: 135 MMOL/L (TESTED ON ANOTHER ANALYZER). SAMPLE 2 (PATIENT 2): INITIAL RESULT: 129 MMOL/L. REPEAT RESULT: 135 MMOL/L (TESTED ON ANOTHER ANALYZER). SAMPLE 3 (PATIENT 3): INITIAL RESULT: 128 MMOL/L. REPEAT RESULT: 134 MMOL/L (TESTED ON ANOTHER ANALYZER). SAMPLE 4 (PATIENT 4): INITIAL RESULT: 132 MMOL/L. REPEAT RESULT: 138 MMOL/L (TESTED ON ANOTHER ANALYZER). SAMPLE 5 (PATIENT 5): INITIAL RESULT: 127 MMOL/L. REPEAT RESULT: 133 MMOL/L (TESTED ON ANOTHER ANALYZER). THE RESULTS WERE REPORTED TO THE EMERGENCY ROOM (ER) AND THE ER PHYSICIAN QUESTIONED THEM. THE SAMPLES WERE THEN REPEATED. THE REPEAT RESULTS WERE DEEMED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18664077 ↗
• MalfunctionJan 30, 2024Output Problem; Non Reproducible Results; Output Problem; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ISE INDIRECT NA FOR GEN.2 RESULTS FROM THREE PATIENT SAMPLES TESTED ON THE COBAS 8000 COBAS ISE MODULE (DOUBLE). THE REPORTER STATED THAT THE NA RESULTS IN THE ION-SELECTIVE ELECTRODE LINE 2 OF THE MODULE SUDDENLY BECAME TOO HIGH PROMPTING THEM TO RERUN THE PATIENT SAMPLES IN THE OTHER LINE. SAMPLE 1: THE INITIAL RESULT FROM LINE 2 WAS 164.7 MMOL/L. THE FIRST REPEAT RESULT FROM LINE 2 WAS 139.5 MMOL/L. THE SECOND REPEAT RESULT FROM THE OTHER LINE WAS 80 MMOL/L. SAMPLE 2: THE INITIAL RESULT FROM LINE 2 WAS 164.7 MMOL/L. THE REPEAT RESULT FROM THE OTHER LINE WAS 114.8 MMOL/L. SAMPLE 3: THE INITIAL RESULT FROM LINE 2 WAS 170 MMOL/L. THE REPEAT RESULT FROM THE OTHER LINE WAS 143.1 MMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18606760 ↗
• MalfunctionJan 29, 2024Output Problem; Non Reproducible Results; Output Problem; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ISE INDIRECT GEN 2 RESULTS FROM THE COBAS 8000 COBAS ISE MODULE. PATIENT 1 INITIAL POTASSIUM RESULT WAS 5.5 MMOL/L AND THE REPEAT RESULT WAS 4.8 MMOL/L. PATIENT 2 INITIAL SODIUM RESULT WAS 149 MMOL/L AND THE REPEAT RESULT WAS 140 MMOL/L. PATIENT 3 INITIAL SODIUM RESULT WAS 148 MMOL/L AND THE REPEAT RESULT WAS 140 MMOL/L. PATIENT 4 INITIAL SODIUM RESULT WAS 132 MMOL/L AND THE REPEAT RESULT WAS 138 MMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18596600 ↗
• MalfunctionJan 25, 2024Mechanical Problem; High Test Results; Mechanical Problem; High Test Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ISE INDIRECT NA FOR GEN.2 RESULTS FROM ONE PATIENT SAMPLE TESTED ON THE COBAS 8000 COBAS ISE MODULE (DOUBLE). THE REPORTER STATED THEY RECEIVED ION-SELECTIVE ELECTRODE (ISE) NOISE ERRORS AND ALARMS. THE INITIAL RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE PHYSICIAN QUESTIONED THE RESULT PROMPTING THE RERUN OF THE PATIENT SAMPLE. THE INITIAL NA RESULT FROM THE MODULE'S ION-SELECTIVE ELECTRODE (ISE) 2 WAS 132 MMOL/L. THE REPEAT RESULT FROM ISE 1 WAS 126 MMOL/L. THE REPEAT RESULT WAS DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18580430 ↗
• MalfunctionJan 23, 2024Low Test Results; Low Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE GEN.2 ISE INDIRECT FOR NA RESULTS FOR APPROXIMATELY 30 PATIENT SAMPLES ON A COBAS 8000 COBAS ISE MODULE. THE CUSTOMER PROVIDED AN EXAMPLE OF ONE PATIENT SAMPLE WITH DISCREPANT NA RESULTS. THE CUSTOMER NOTICED MOVING RESULT AVERAGES WERE DRIFTING LOW. THE CUSTOMER RE-CALIBRATED, REPLACED THE NA ELECTRODE, REPLACED ISE REAGENTS, AND REPEATED CONTROLS, BUT THERE WAS NO CHANGE. THE CUSTOMER THEN REPEATED THE AFFECTED PATIENT SAMPLES ON A SECOND ISE MODULE THE INITIAL NA RESULT WAS 136 MMOL/L. THE SAMPLE WAS REPEATED ON ANOTHER ISE MODULE AND THE RESULT WAS 143 MMOL/L. THE REPEAT RESULT WAS DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18563416 ↗
• MalfunctionJan 23, 2024Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ISE INDIRECT NA AND K FOR GEN.2 RESULTS FROM AN UNSPECIFIED NUMBER OF PATIENT SAMPLES TESTED ON THE COBAS 8000 COBAS ISE MODULE (DOUBLE). THE REPORTER STATED THEY HAD ION-SELECTIVE ELECTRODE (ISE) VOLTAGE, NOISE, AND CALIBRATION ERRORS. THE REPORTER WAS ABLE TO PROVIDE THREE EXAMPLES OF DISCREPANT RESULTS. SAMPLE 1 THE INITIAL NA RESULT FROM ISE 2 WAS 85 MMOL/L. THE FIRST REPEAT RESULT FROM ISE 1 WAS 137 MMOL/L. THE SECOND REPEAT RESULT FROM ISE 1 WAS 137 MMOL/L. THE INITIAL K RESULT FROM ISE 2 WAS 2.8 MMOL/L. THE FIRST REPEAT RESULT FROM ISE 1 WAS 4.4 MMOL/L. THE SECOND REPEAT RESULT FROM ISE 1 WAS 4.5 MMOL/L. SAMPLE 2 THE INITIAL K RESULT FROM ISE 2 WAS 7.8 MMOL/L. THE FIRST REPEAT RESULT FROM ISE 1 WAS 4 MMOL/L. THE SECOND REPEAT RESULT FROM ISE 1 WAS 4 MMOL/L. SAMPLE 3 THE INITIAL NA RESULT FROM ISE 2 WAS 93 MMOL/L. THE FIRST REPEAT RESULT FROM ISE 2 WAS 117 MMOL/L. THE SECOND REPEAT RESULT FROM ISE 1 WAS 126 MMOL/L. THE THIRD REPEAT RESULT FROM ISE 1 WAS 128 MMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18562229 ↗
• MalfunctionJan 22, 2024Mechanical Problem; Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results; Mechanical Problem; Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results

  WE RECEIVED AN ALLEGATION OF QUESTIONABLE ISE RESULTS FOR 2 PATIENTS' SAMPLES TESTED ON A COBAS 8000 COBAS ISE MODULE WHEN COMPARED TO A DIFFERENT COBAS 8000 COBAS ISE MODULE. RESULTS FOR THE SODIUM (NA) TEST WERE AFFECTED: SAMPLE 1 (PATIENT 1): INITIAL RESULT: 131 MMOL/L. REPEAT RESULT: 139 MMOL/L. SAMPLE 2 (PATIENT 2): INITIAL RESULT: 127 MMOL/L. REPEAT RESULT: 137 MMOL/L. QC WAS WITHIN RANGES PRIOR TO RUNNING THE PATIENTS' SAMPLES. THE CUSTOMER THEN NOTICED A MOVING AVERAGE ERROR PROMPTING THE RERUN OF THE SAMPLES. THE REPEAT RESULTS WERE DEEMED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18553104 ↗
• MalfunctionJan 22, 2024Non Reproducible Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ISE INDIRECT GEN 2 SODIUM RESULTS FROM THE COBAS 8000 COBAS ISE MODULE. ONE EXAMPLE WAS PROVIDED OF AN INITIAL RESULT >180 MMOL/L AND A REPEAT RESULT OF 140 MMOL/L. THE QUESTIONABLE RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18551745 ↗
• MalfunctionJan 18, 2024Low Test Results; Low Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ISE INDIRECT GEN 2 SODIUM RESULTS FROM THE COBAS 8000 COBAS ISE MODULE. PATIENT 1 INITIAL RESULT WAS 133 MMOL/L AND THE REPEAT RESULT WAS 139 MMOL/L. PATIENT 2 INITIAL RESULT WAS 133 MMOL/L AND THE REPEAT RESULT WAS 142 MMOL/L. PATIENT 3 INITIAL RESULT WAS 128 MMOL/L AND THE REPEAT RESULT WAS 134 MMOL/L. THE REPEAT RESULTS WERE DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18535989 ↗
• MalfunctionJan 12, 2024Imprecision; Non Reproducible Results; Imprecision; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE GEN.2 ISE INDIRECT FOR NA RESULTS FOR 1 PATIENT SAMPLE ON A COBAS 8000 COBAS ISE MODULE. THE INITIAL NA RESULT WAS 136 MMOL/L. THE REPEAT RESULT WAS 130 MMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18502938 ↗
• MalfunctionJan 10, 2024Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER QUESTIONED ISE RESULTS FOR MULTIPLE PATIENT SAMPLES TESTED ON A COBAS 8000 ISE 1800 MODULE. DISCREPANT RESULTS WERE PROVIDED FOR 1 PATIENT SAMPLE TESTED FOR NA ELECTRODE (NA). THE INITIAL RESULT WAS 125 MMOL/L. THE REPEAT RESULT WAS 139 MMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18482921 ↗
• MalfunctionJan 9, 2024Low Test Results; Low Test Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ISE INDIRECT K FOR GEN. 2 RESULTS FROM TWO PATIENT SAMPLES TESTED ON THE COBAS 8000 COBAS ISE MODULE (DOUBLE). THE INITIAL RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE INITIAL RESULTS WERE DEEMED QUESTIONABLE PROMPTING THE RERUN OF THE PATIENT SAMPLES ON THEIR OTHER COBAS 8000 ISE MODULE. SAMPLE 1 THE INITIAL K RESULT FROM THE MODULE WITH THE PATIENT SAMPLE IN THE PRIMARY TUBE WAS (B)(6). THE REPEAT RESULT FROM THE OTHER MODULE WITH THE PATIENT SAMPLE IN THE PRIMARY TUBE WAS (B)(6). SAMPLE 2 THE INITIAL K RESULT FROM THE MODULE OF THE ALIQUOTED PATIENT SAMPLE WAS (B)(6). THE REPEAT RESULT FROM THE OTHER MODULE OF THE ALIQUOTED PATIENT SAMPLE WAS (B)(6). THE REPEAT RESULTS WERE DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18476438 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K100853. One submission often covers many models, so check the product and lot details in each record.

• Z-0754-2021 · Dec 8, 2020 · Open, Classified
  Roche cobas 8000 modular analyzer series (i.e., cobas 8000 ISE module; cobas c 502, 701, and 702 modules; and cobas e 602 and 801 modules). Chemistry Analyzer (photometric discrete
• Z-2477-2019 · Jul 18, 2019 · Terminated
  Cobas 8000 Modular Analyzer Series: cobas 8000 ISE module part Numbers : 05964075001 cobas c 701 module part Numbers : 05641489001 cobas c 702 module part Numbers : 06473245
• Z-1249-2019 · Mar 15, 2019 · Terminated
  cobas e 801 immunoassay analyzer
• Z-2136-2018 · Apr 3, 2018 · Terminated
  cobas e 801 immunoassay analyzer, cobas 8000 Modular Series The device is a fully automated, software controlled analyzer system for in vitro determination of analytes in human bo
• Z-0675-2018 · Jul 28, 2017 · Terminated
  Cobas 8000 Modular Series system; Software Version 05-02 and 06-03; UDI: 05641446001
• Z-0910-2018 · Jul 18, 2017 · Terminated
  cobas 8000 Modular Analyzer Series; Part Numbers: 1. 05964067001 cobas 8000 c 502 module
• 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-0097-2017 · Jul 15, 2016 · Terminated
  cobas 8000 Modular Analyzer Series c8000, Chemistry (Photometric, Discrete) for clinical use Modular e602: Immunoassay Analyzer Product Usage: The VS II system is a stand-alone, c
• Z-1449-2014 · Mar 13, 2014 · Terminated
  Cobas c8000 Modular Analyzer Series Cobas c502, Part Number 5964067001, a clinical chemistry analyzer intended for the in vitro quantitative / qualitative determination of analyt
• Z-1368-2013 · Apr 4, 2013 · Terminated
  Cobas 8000 modular analyzer series software version 03-01, 02, 03 and 04, impacting the cobas e 602 module only. Product Usage: Fully automated immunoassay analyzer intended for