Elecsys Insulin 07027559190Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 04015630940042), received between Jul 20, 2018 and Sep 24, 2026 — classified as 18 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, 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026High Test Results; Low Test Results; Output Problem; Non Reproducible Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50882712 ↗
• MalfunctionSep 21, 2026High Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50847318 ↗
• MalfunctionOct 29, 2025Low Test Results; Low Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS INSULIN RESULTS FOR 1 PATIENT SAMPLE ON A COBAS E 801 ANALYTICAL UNIT COMPARED TO AN ABBOTT ALINITY ANALYZER. THE E801 RESULT WAS 0.4 UIU/ML. THE DOCTOR QUESTIONED THE RESULT AS IT DID NOT MATCH THE PATIENT'S CLINICAL STATUS. THE SAMPLE WAS REPEATED ON THE ALINITY ANALYZER AND THE RESULT WAS 20 UIU/ML. THE SAMPLE WAS REPEATED AGAIN ON ANOTHER E801 ANALYZER AND THE RESULT WAS 0.2 UIU/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23416804 ↗
• MalfunctionOct 23, 2025Incorrect Measurement; Low Test Results; Non Reproducible Results; Incorrect Measurement; Low Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS INSULIN RESULTS FOR 2 PATIENT SAMPLES ON A COBAS E 801 MODULE. THE CUSTOMER QUESTIONED THE INITIAL RESULTS AS THEY DID NOT MATCH THE C-PEPTIDE RESULTS. ON (B)(6) 2025, SAMPLE 1 HAD AN INITIAL RESULT OF <3 PMOL/L. THE REPEAT RESULT WAS 34 PMOL/L. ON (B)(6) 2025, SAMPLE 2 HAD AN INITIAL RESULT OF <3 PMOL/L. THE REPEAT RESULT WAS 50 PMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23368632 ↗
• MalfunctionJun 12, 2025Incorrect Measurement; Low Test Results; Compatibility Problem; Incorrect Measurement; Low Test Results; Compatibility Problem

  THE INITIAL REPORTER COMPLAINED OF DISCREPANT LOW RESULTS FOR 2 PATIENT SAMPLES TESTED FOR ELECSYS INSULIN (INSULIN) ON A COBAS E 801 ANALYTICAL UNIT. PATIENT 1 INITIAL RESULT WAS < 0.4 UU/ML. THE REPEAT RESULT FROM A COMPETITOR METHOD WAS 26.6 MIU/L PATIENT 2 INITIAL RESULT WAS < 0.4 UU/ML. THE REPEAT RESULT FROM A COMPETITOR METHOD WAS 67.2 MIU/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22194073 ↗
• MalfunctionMay 8, 2025Low Test Results; Low Test Results

  THE INITIAL REPORTER COMPLAINED OF DISCREPANT LOW RESULTS FOR 2 PATIENT SAMPLES TESTED FOR ELECSYS INSULIN (INSULIN) ON A COBAS 8000 CORE UNIT. PATIENT 1 INITIAL RESULT WAS 3.94 PMOL/L. THE REPEAT RESULT WAS 401 PMOL/L. PATIENT 2 INITIAL RESULT WAS 39.5 PMOL/L. THE REPEAT RESULT WAS 1383 PMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21986496 ↗
• MalfunctionApr 24, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS INSULIN RESULTS FROM THE COBAS E 801 ANALYTICAL UNIT. THE INITIAL RESULT WAS 3.66 MIU/ML. ON (B)(6) 2025, THE REPEAT RESULT WAS 1.66 MIU/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21900556 ↗
• MalfunctionApr 26, 2024High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS INSULIN RESULTS FOR 1 PATIENT ON A COBAS E 801 MODULE COMPARED TO A SIEMENS ANALYZER. ON (B)(6) 2024, A NEW SAMPLE WAS COLLECTED FROM THE SAME PATIENT AND THE INSULIN RESULT WAS 936 UUI/ML. THE SAMPLE WAS REPEATED AND THE RESULT WAS 904 UUI/ML. ON (B)(6) 2024, SAMPLE WAS REPEATED ON A SIEMENS ANALYZER AND THE RESULT WAS 24.7 UUI/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19197297 ↗
• MalfunctionApr 16, 2024Incorrect Measurement; High Test Results; Incorrect Measurement; High Test Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SERUM/PLASMA SAMPLE TESTED WITH ELECSYS INSULIN ASSAY ON A COBAS E801 IMMUNOASSAY ANALYZER WHEN COMPARED TO RIA METHOD. INITIAL RESULT: >1000 UIU/ML. ON (B)(6) 2024 THE SAMPLE WAS TESTED AT VARIOUS DILUTION FACTORS. 1:32 DILUTION RESULTED IN 50.8 UIU/ML. 1:16 DILUTION RESULTED IN 92.0 UIU/ML. 1:8 DILUTION RESULTED IN 176 UIU/ML. 1:4 DILUTION RESULTED IN 321 UIU/ML. 1:2 DILUTION RESULTED IN 616 UIU/ML. ALL THE DILUTION RESULTS WERE INTERPRETED AS SIMILAR TO THE INITIAL RESULT. THE ORIGINAL SAMPLE WAS TESTED WITH 20% PEG PRETREATMENT AND THE RESULT WAS 444 UIU/ML. THE ORIGINAL SAMPLE WAS TESTED FOR ANTI-INSULIN AB USING THE CIA METHOD AND THE RESULT WAS >175 IU/ML (REFERENCE VALUE: <20.0 IU/ML). THE ORIGINAL SAMPLE WAS THEN TESTED FOR INSULIN USING THE RIA METHOD AND THE RESULT WAS 13.09 NG/ML (REFERENCE INTERVAL: 4-16 NG/ML). THE SAMPLE WAS ALSO TESTED FOR PROINSULIN AND THE RESULT WAS 24.4. THE UNIT OF MEASUREMENT WAS NOT PROVIDED. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19118301 ↗
• MalfunctionMar 17, 2023High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS INSULIN ON A COBAS E 801 MODULE (SERIAL NUMBER (B)(4)). NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE INITIALLY RESULTED IN AN INSULIN VALUE OF 37.2 UU/ML AND IT REPEATED AS 19.2 UU/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16567198 ↗
• MalfunctionNov 29, 2022Low 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 ELECSYS INSULIN ON A COBAS 8000 E 801 MODULE. NO INCORRECT RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE INITIALLY RESULTED IN AN INSULIN VALUE OF 0.778 UU/ML AND REPEATED AS 7.24 UU/ML. THE REPEAT VALUE WAS CONSIDERED CORRECT. THE INSULIN REAGENT LOT NUMBER WAS 63345601. THE REAGENT EXPIRATION DATE WAS REQUESTED, BUT NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15880345 ↗
• MalfunctionMay 19, 2022Incorrect Measurement; High Test Results; Incorrect Measurement; High Test Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS INSULIN RESULTS FOR ONE PATIENT TESTED WITH A COBAS 8000 E 801 MODULE SERIAL NUMBER (B)(4). THE PATIENT'S INITIAL ELECSYS INSULIN RESULT WAS NOT REPORTED OUTSIDE THE LABORATORY. THE CUSTOMER PERFORMED DILUTION TESTING WITH THE SAMPLE. FOR FURTHER TESTING, THE CUSTOMER SENT THE SAMPLE TO A DIFFERENT LABORATORY AND THE SAMPLE WAS TESTED ON AN ALINITY ANALYZER. THE PATIENT'S INITIAL INSULIN RESULT WAS 1000 UU/ML WITH A DATA FLAG. THE PATIENT'S INSULIN RESULT WITH A 1:5 DILUTION WAS 3755 UU/ML. THE PATIENT'S INSULIN RESULT WITH A 1:10 DILUTION WAS 3800 UU/ML. THE PATIENT'S INSULIN RESULT ON THE ALINITY ANALYZER WAS 280 UU/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14438272 ↗
• MalfunctionApr 25, 2022Incorrect Measurement; High Test Results; Incorrect Measurement; High Test Results

  THE INITIAL REPORTER COMPLAINED OF A DISCREPANT HIGH RESULT FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS INSULIN (INSULIN) ON A COBAS E 801 ANALYTICAL UNIT COMPARED TO THE SIEMENS METHOD. THE 2 HOUR POST-PRANDIAL RESULT FROM THE E801 UNIT WAS >1000 UU/ML. THE SAMPLE WAS TESTED BY THE SIEMENS METHOD WITH A RESULT OF 101 UIU/ML. THE QUESTIONABLE RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE E801 UNIT SERIAL NUMBER WAS (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14193593 ↗
• MalfunctionMar 31, 2022Incorrect Measurement; High Test Results; Incorrect Measurement; High Test Results

  THE INITIAL REPORTER QUESTIONED RESULTS FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS INSULIN (INSULIN) ON A COBAS E801 MODULE. THE INITIAL INSULIN RESULT FROM THE E801 MODULE WAS >1000 (THE UNIT OF MEASURE WAS NOT PROVIDED). THE REPEAT RESULT WITH A 1:20 DILUTION FROM THE E801 MODULE WAS 3760. THE REPEAT RESULT WITH A 1:40 DILUTION FROM THE E801 MODULE WAS 3856. THE SAMPLE WAS TESTED BY THE ABBOTT METHOD AND THE RESULT FROM AN UNSPECIFIED DILUTION WAS 8024 (THE UNIT OF MEASURE WAS NOT PROVIDED). NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE E801 MODULE SERIAL NUMBER WAS 1743-03.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13963466 ↗
• MalfunctionMar 11, 2022High Test Results; High Test Results

  THE INITIAL REPORTER STATED THEY HAVE RECEIVED QUESTIONABLE TEST RESULTS FOR ONE PATIENT TESTED WITH ELECSYS INSULIN ON A COBAS 8000 E 801 MODULE. IT WAS ASKED, BUT IT IS NOT KNOWN IF ANY INCORRECT VALUES WERE REPORTED OUTSIDE OF THE LABORATORY. THE REPORTER STATES THAT THE PATIENT SHOWED VERY HIGH INSULIN VALUES > 6000 WHEN THE PATIENT IS UNDER THE ADMINISTRATION OF ACRAPID INSULIN. NO UNITS OF MEASURE WERE PROVIDED FOR INSULIN. WHEN THE PATIENT IS UNDER THERAPY WITH LANTUS AND APIDRA INSULINS, THE INSULIN VALUES OF THE PATIENT ARE VERY LOW AT 10-20. THE SERIAL NUMBER OF THE E 801 ANALYZER IS (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13731424 ↗
• MalfunctionAug 19, 2021High Test Results; High Test Results

  THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS INSULIN (INSULIN) AND ELECSYS C-PEPTIDE (C-PEPTIDE) ON A COBAS E801 MODULE COMPARED TO THE BECKMAN METHOD. THIS MEDWATCH WILL COVER THE INSULIN RESULTS. REFER TO MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE C-PEPTIDE RESULTS. THE INITIAL INSULIN RESULT FROM THE E801 MODULE WAS 1000 UU/ML WITH A DATA FLAG. THE INITIAL C-PEPTIDE RESULT FROM THE E801 MODULE WAS 34.9 NG/ML. THE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY WHERE THEY WERE QUESTIONED BY THE DOCTOR. ON (B)(6) 2021 THE SAMPLE WAS SENT TO AN EXTERNAL LABORATORY USING THE BECKMAN METHOD AND THE INSULIN RESULT WAS 136.13 UU/ML AND THE C-PEPTIDE RESULT WAS 20.35 NG/ML. THE CUSTOMER DOES NOT KNOW WHICH RESULTS ARE CORRECT AND SUSPECTS AN INTERFERENCE. THE E801 MODULE SERIAL NUMBER WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12342276 ↗
• MalfunctionSep 21, 2018High Test Results; High Test Results

  THE CUSTOMER STATED THAT THEY RECEIVED ERRONEOUS RESULTS FOR TWO SAMPLES FROM THE SAME PATIENT TESTED WITH ELECSYS INSULIN ON A COBAS 8000 E 801 MODULE. IT WAS ASKED, BUT IT IS NOT KNOWN IF THE ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE FIRST SAMPLE INITIALLY RESULTED WITH AN INSULIN VALUE OF 53.2 UU/ML WHEN TESTED ON THE E 801 ANALYZER. THE SAMPLE WAS REPEATED ON THE E 801 ANALYZER ON (B)(4) 2018, RESULTING WITH AN INSULIN VALUE OF 49.9 UU/ML. THE SECOND SAMPLE RESULTED WITH AN INSULIN VALUE OF 49.6 UU/ML WHEN TESTED ON THE E 801 ANALYZER. THE SAMPLES WERE SENT TO OTHER LABORATORIES FOR TESTING ON SIEMENS CENTAUR ANALYZERS, RESULTING WITH VALUES OF 7.8 UU/ML AND 7.6 UU/ML. IT IS NOT KNOWN WHICH OF THE TWO SAMPLES EACH OF THE TWO REPEAT VALUES CORRESPOND TO. NO ADVERSE EVENTS WERE ALLEGED TO HAVE OCCURRED WITH THE PATIENT . THE E 801 ANALYZER SERIAL NUMBER WAS (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7897525 ↗
• MalfunctionJul 20, 2018High Test Results; High Test Results

  THE CUSTOMER QUESTIONED HIGH RESULTS FOR 2 SAMPLES DRAWN ON (B)(6) 2018 FROM 1 PATIENT TESTED FOR ELECSYS INSULIN (INSULIN) ON A COBAS E 801 MODULE. THE CUSTOMER SUSPECTS AN INTERFERENCE IN THE PATIENT SAMPLE AS THE RESULTS DON'T CORRESPOND TO PATIENT'S CLINICAL PICTURE. THE FIRST SAMPLE WAS OBTAINED AFTER 4 HOURS FASTING AND HAD AN INITIAL INSULIN RESULT OF 97.1 UU/ML. THE 2ND SAMPLE WAS OBTAINED AFTER 16 HOURS FASTING AND HAD AN INSULIN RESULT OF 87.4 UU/ML. THE HIGH INSULIN RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO ALLEGATION THAT AN ADVERSE EVENT OCCURRED. THE E801 MODULE SERIAL NUMBER WAS (B)(4). ON (B)(6) 2018 THE CUSTOMER PERFORMED INTERFERENCE TESTING ON THE 2 SAMPLES: AFTER SCANTIBODIES HBT TREATMENT, THE INSULIN RESULTS WERE 92.7 UU/ML FOR THE 1ST SAMPLE AND 86.6 UU/ML FOR THE 2ND SAMPLE. THE 2 SAMPLES WERE ALSO TREATED AND UNDERWENT POLYETHYLENE GLYCOL (PEG) TESTING WHERE THE INSULIN RESULT FOR THE 1ST SAMPLE WAS 4.03 UU/ML (CALCULATED RESULT OF 16.12 UU/ML) AND THE INSULIN RESULT FOR THE 2ND SAMPLE WAS 3.30 UU/ML (CALCULATED RESULT OF 13.2 UU/ML). BOTH SAMPLES WERE SUBMITTED FOR INVESTIGATION AND TESTED ON AN E 801 MODULE WITH INSULIN REAGENT LOT NUM

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7706083 ↗