Elecsys Insulin 12017547122Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 04015630913060), received between Jan 28, 2019 and Oct 18, 2024 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (7 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 18, 2024Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS INSULIN RESULTS FOR 6 PATIENT SAMPLES ON A COBAS 8000 - COBAS E 602 MODULE. THE CUSTOMER QUESTIONED THE LOW INITIAL RESULTS WHICH PROMPTED THEM TO REPEAT THE PATIENT SAMPLES. ON (B)(6) 2024, SAMPLE 1 HAD AN INITIAL INSULIN RESULT OF 16.66 UU/ML. THE SAMPLE WAS REPEATED ON ANOTHER E602 ANALYZER AND THE RESULT WAS 21.1 UU/ML. ON (B)(6) 2024, SAMPLE 2 HAD AN INITIAL INSULIN RESULT OF 7.10 UU/ML. THE SAMPLE WAS REPEATED ON ANOTHER E602 ANALYZER AND THE RESULT WAS 14.1 UU/ML. ON (B)(6) 2024, THE SAMPLE WAS REPEATED ON THE INITIAL E602 ANALYZER AND THE RESULT WAS 14.88 UU/ML. ON (B)(6) 2024, SAMPLE 3 HAD AN INITIAL INSULIN RESULT OF 17.25 UU/ML. THE SAMPLE WAS REPEATED ON ANOTHER E602 ANALYZER AND THE RESULT WAS 35 UU/ML. ON (B)(6) 2024, THE SAMPLE WAS REPEATED ON THE INITIAL E602 ANALYZER AND THE RESULT WAS 35.23 UU/ML. ON (B)(6) 2024, SAMPLE 4 HAD AN INITIAL INSULIN RESULT OF 3.21 UU/ML. THE SAMPLE WAS REPEATED ON ANOTHER E602 ANALYZER AND THE RESULT WAS 11.9 UU/ML. ON (B)(6) 2024, THE SAMPLE WAS REPEATED ON THE INITIAL E602 ANALYZER AND THE RESULT WAS 11.18 UU/ML. ON (B)(6) 2024, SAMPLE 5 HAD AN INITIAL INSULIN RESULT OF 6.90 UU/ML. THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20486535 ↗
• MalfunctionJul 8, 2024High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS INSULIN (INSULIN) ON A COBAS E 411 ANALYZER (DISK SYSTEM). THE INITIAL RESULT WAS 29.5 IUI/ML. THE SAMPLE WAS REPEATED TWICE WITH RESULTS OF 0.2 IUI/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19690586 ↗
• MalfunctionSep 26, 2023Incorrect Measurement; High Test Results; Incorrect Measurement; High Test Results

  THE INITIAL REPORTER COMPLAINED OF HIGH RESULTS FOR 2 SAMPLES FROM 1 PATIENT TESTED FOR ELECSYS INSULIN (INSULIN) ON A COBAS E 411 IMMUNOASSAY ANALYZER. ON (B)(6) 2023 THE PATIENT HAD AN INSULIN RESULT OF 962.8 UU/ML WITH A DATA FLAG FROM THE E411 ANALYZER. THE REPEAT RESULT WAS 960.8 UU/ML WITH A DATA FLAG. ON (B)(6) 2023 A NEW SAMPLE WAS OBTAINED AND THE RESULT FROM THE E411 ANALYZER WAS 966.0 UU/ML WITH A DATA FLAG. THIS SAMPLE WAS SENT TO ANOTHER LABORATORY WHERE THE RESULT FROM THE MAGLUMI METHOD WAS 99.61 UU/ML AND THE RESULT FROM THE ATELLICA METHOD WAS 31.03 UU/ML

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17817409 ↗
• MalfunctionMar 14, 2023Incorrect Measurement; High Test Results; Incorrect Measurement; High Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE RESULTS FOR ONE PATIENT SAMPLE TESTED WITH THE ELECSYS INSULIN ASSAY ON A COBAS 6000 E601 MODULE, SERIAL NUMBER 26E4-17. AN INTERFERENCE IS SUSPECTED BY THE CUSTOMER. ON (B)(6) 2023, A FIRST SAMPLE FROM THE PATIENT RESULTED IN AN INSULIN VALUE OF >1000 U/L, ACCOMPANIED BY A DATA FLAG AND REPEATED ALSO WITH A VALUE OF >1000 U/L, ACCOMPANIED BY A DATA FLAG. ON (B)(6) 2023, A SECOND SAMPLE FROM THE PATIENT RESULTED IN AN INSULIN VALUE OF >1000 U/L, ACCOMPANIED BY A DATA FLAG. THIS SAMPLE WAS REPEATED IN A DIFFERENT LABORATORY USING AN UNKNOWN METHOD, RESULTING IN AN INSULIN VALUE OF 261 MUI/ML. THE QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16541581 ↗
• MalfunctionDec 20, 2022Incorrect Measurement; Low Test Results; Incorrect Measurement; Low Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE RESULTS FOR ONE PATIENT SAMPLE TESTED WITH THE ELECSYS INSULIN ASSAY ON A COBAS 6000 E601 MODULE, SERIAL NUMBER (B)(4). THE RESULT DID NOT AGREE WITH THE PATIENT'S CLINICAL MANIFESTATION AND THE VALUES MEASURED USING A COMPETITOR METHOD. THE SAMPLE INITIALLY RESULTED IN AN INSULIN VALUE OF 11.31 UU/ML AND REPEATED AS 11.47 UU/ML ON A SECOND E601 MODULE. THE SAMPLE VALUES WERE REPORTED OUTSIDE OF THE LABORATORY TO THE DOCTOR AND QUESTIONED. THE SAMPLE WAS THEN REPEATED USING A COMPETITOR METHOD, RESULTING IN AN INSULIN VALUE OF 300 UU/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16019356 ↗
• MalfunctionDec 20, 2022Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE RESULTS FROM THE COBAS E411 RACK ANALYZER. PATIENT 1 INITIAL TOTAL PSA ELECSYS RESULT WAS 0.02 NG/ML AND WAS REPORTED OUTSIDE OF THE LABORATORY. THE TREATING PHYSICIAN QUESTIONED THE RESULT AS IT DID NOT MATCH THE PATIENT'S CLINICAL HISTORY. ON (B)(6) 2022, THE REPEAT RESULT WAS 1.29 NG/ML. ON (B)(6) 2022, PATIENT 2 INITIAL INSULIN ELECSYS RESULT WAS 0.04 UU/ML AND WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THE REPEAT RESULT WAS 27 UU/ML. THE TOTAL PSA REAGENT LOT NUMBER WAS 648973 WITH AN EXPIRATION DATE OF 31-JAN-2024. THE INSULIN REAGENT LOT NUMBER WAS 586607 WITH AN EXPIRATION DATE OF 31-MAR-2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16016109 ↗
• MalfunctionOct 25, 2022Incorrect Measurement; Low Test Results; Incorrect Measurement; Low Test Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS INSULIN RESULTS FOR ONE PATIENT TESTED ON A COBAS 8000 E601 MODULE SERIAL NUMBER (B)(4). ON (B)(6) 2022, THE INITIAL INSULIN RESULT WAS 0.200 U/ML, AND IT WAS ACCOMPANIED BY A DATA FLAG. THE REPEAT RESULT WAS 0.221 U/ML. ON (B)(6) 2022, THE REPEAT RESULT PERFORMED ON A COMPETITOR INSTRUMENT (CHEMILUMINESCENCE INSTRUMENT) WAS 118 MU/L. ON (B)(6) 2022, THE REPEATED RESULT WAS PERFORMED ON THE COBAS 8000 E601 MODULE AND THE RESULT WAS 0.343 U/ML AND 0.310 U/ML. ON (B)(6) 2022, THE REPEATED RESULT WAS PERFORMED ON THE COBAS 8000 E601 MODULE AND THE RESULT WAS 1.15 U/ML, WITH A DILUTION RATIO OF 2:1. THE QUESTIONABLE RESULTS WERE REPORTED OUTSIDE THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15668363 ↗
• MalfunctionNov 19, 2021Incorrect Measurement; Low Test Results; Incorrect Measurement; Low Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS INSULIN ON TWO COBAS 8000 E 602 MODULES. THE RESULTS DID NOT COMPARE TO VALUES OBTAINED WITH A COMPETITOR METHOD. IT WAS ASKED, BUT IT IS NOT KNOWN IF ANY INCORRECT RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE WAS INITIALLY TESTED ON THE CUSTOMER'S IMMULITE 2000 XPI PLATFORM, RESULTING IN AN INSULIN VALUE OF 204 UUI/ML. THE SAMPLE WAS REPEATED ON THE IMMULITE SYSTEM, RESULTING IN A VALUE THAT WAS SIMILAR, APPROXIMATELY 200 UUI/ML. THE SAMPLE WAS SENT TO A SECOND SITE FOR TESTING ON E 602 ANALYZER SERIAL NUMBER (B)(4), RESULTING IN AN INSULIN VALUE OF < 0.200 UUI/ML ACCOMPANIED BY A DATA FLAG. THE SAMPLE WAS ALSO SENT TO A THIRD SITE FOR TESTING ON A SECOND E 602 ANALYZER (SERIAL NUMBER UNKNOWN), RESULTING IN A VALUE OF < 0.200 UUI/ML ACCOMPANIED BY A DATA FLAG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12845205 ↗
• MalfunctionSep 24, 2021Incorrect Measurement; Low Test Results; Incorrect Measurement; Low Test Results

  THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 3 SAMPLES FROM 1 PATIENT TESTED FOR ELECSYS INSULIN (INSULIN) ON A COBAS 8000 E 602 MODULE COMPARED TO THE ARCHITECT METHOD. THE ROCHE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY WHERE THEY WERE QUESTIONED AS THEY DID NOT CORRESPOND TO THE PATIENT¿S CLINICAL DIAGNOSIS AND REPEAT TESTING BY ANOTHER ANALYZER WAS REQUESTED. THE PATIENT HAD COME TO THE HOSPITAL DUE TO SYMPTOMS OF HYPOGLYCEMIA. ON (B)(6) 2021 THE RESULT ON THE E602 MODULE WAS 19.1 UU/ML. THE RESULT FROM THE ARCHITECT METHOD WAS 300 UU/ML. ON THE MORNING OF (B)(6) 2021 THE RESULT FROM THE 2ND SAMPLE ON THE E602 MODULE WAS 0.4 UU/ML. THE RESULT FROM THE ARCHITECT METHOD WAS 92.98 UU/ML. ON THE AFTERNOON OF (B)(6) 2021 THE RESULT FROM THE 3RD SAMPLE ON THE E602 MODULE WAS 6.0 UU/ML. THE RESULT FROM THE ARCHITECT METHOD WAS 263.93 UU/ML. THE CUSTOMER BELIEVES THE ARCHITECT RESULTS TO BE CORRECT. THE E602 MODULE SERIAL NUMBER WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12526401 ↗
• MalfunctionApr 26, 2019High Test Results; High Test Results

  THIS REPORT SUMMARIZES <NOE>1</NOE> MALFUNCTION EVENTS. ERRONEOUS HIGH RESULTS WERE GENERATED BY A COBAS 6000 E 601 MODULE. THE EVENT INVOLVED 1 PATIENT WITH ELECSYS INSULIN. THE PROVIDED PATIENT'S AGE WAS (B)(6). THE PATIENT'S GENDER WAS FEMALE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8556052 ↗
• MalfunctionJan 28, 2019High Test Results; High Test Results

  THIS REPORT SUMMARIZES <NOE>1</NOE> MALFUNCTION EVENT. AN ERRONEOUS HIGH RESULT WAS GENERATED BY THE COBAS 8000 E 602 MODULE. THE EVENTS INVOLVED A TOTAL OF ONE PATIENT WITH THE FOLLOWING: ONE ERRONEOUS RESULT FOR ELECSYS INSULIN. THE PATIENT'S AGE WAS (B)(6). THE PATIENT'S WEIGHT WAS REQUESTED, BUT NOT PROVIDED. THERE WAS ONE FEMALE. THE PATIENT'S RACE WAS REQUESTED, BUT NOT PROVIDED. THE PATIENT'S ETHNICITY WAS REQUESTED, BUT NOT PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8281235 ↗
• MalfunctionJan 28, 2019Low Test Results; Low Test Results

  THIS REPORT SUMMARIZES <NOE>1</NOE> MALFUNCTION EVENT. LOW RESULTS WERE GENERATED BY THE COBAS 8000 E 602 MODULE. THE EVENT INVOLVED 1 PATIENT WITH LOW RESULTS FOR ELECSYS INSULIN. THE PATIENT'S AGE WAS REQUESTED, BUT WAS NOT PROVIDED. THE PATIENT'S WEIGHT WAS REQUESTED, BUT WAS NOT PROVIDED. THE PATIENT'S GENDER WAS REQUESTED, BUT WAS NOT PROVIDED. THE PATIENT'S RACE WAS REQUESTED, BUT WAS NOT PROVIDED. THE PATIENT'S ETHNICITY WAS REQUESTED, BUT WAS NOT PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8280769 ↗