Elecsys C-Peptide 07027168190Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04015630939992), received between Aug 19, 2021 and Aug 25, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “High Test Results” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 25, 2025High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS C-PEPTIDE RESULTS FROM THE COBAS E 801 MODULE. THE INITIAL RESULT WAS 2.26 NMOL/L. THE REPEAT RESULT WAS 0.01 NMOL/L. THE QUESTIONABLE RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22883104 ↗
• MalfunctionDec 12, 2022Incorrect Measurement; High Test Results; Incorrect Measurement; High Test Results

  THE INITIAL REPORTER RECEIVED A QUESTIONABLE ELECSYS C-PEPTIDE (C-PEPTIDE) RESULT FROM ONE PATIENT SAMPLE TESTED ON THE COBAS E 801 ANALYTICAL UNIT WITH SERIAL NUMBER (B)(4). THE INITIAL RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE C-PEPTIDE RESULT ALLEGEDLY DID NOT FIT OR WAS NOT PARALLEL TO THE MEASURED ELECSYS INSULIN RESULT. THE INITIAL C-PEPTIDE RESULT WAS >40 NG/ML. THE REPORTER DID A RECYCLING EXPERIMENT WITH POLYETHYLENE GLYCOL (PEG) AND THE RESULT WAS CONSISTENT WITH THE ORIGINAL RESULT. THE INSULIN RESULT WAS 18.2 UU/ML. THIS RESULT WAS WITHIN THE MEASUREMENT RANGE BUT HIGHER THAN THE REFERENCE INTERVAL. THE PATIENT SAMPLE WAS RETESTED FOR INSULIN AND THE RESULTS WERE CONSISTENT THE REAGENT LOT NUMBER AND THE EXPIRATION DATE WERE REQUESTED BUT NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15959558 ↗
• 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 C-PEPTIDE. REFER TO MEDWATCH WITH A1 PATIENT IDENTIFIER PT-59788 FOR INFORMATION ON THE INSULIN 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 12342278 ↗