Triglycerides 08058687190Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 07613336121542), received between Jan 26, 2023 and Sep 1, 2026 — classified as 21 malfunctions.

The most frequently reported specific device problem is “Non Reproducible 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 1, 2026High Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50539341 ↗
• MalfunctionAug 5, 2026Non Reproducible Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50139372 ↗
• MalfunctionMay 18, 2026Incorrect, Inadequate or Imprecise Result or Readings

  THE INITIAL REPORTER RECEIVED QUESTIONABLE TRIGLYCERIDES (TRIGL) ASSAY RESULTS FROM ONE PATIENT'S SAMPLE TESTED ON THE COBAS C 503 ANALYTICAL UNIT. THE INITIAL RESULT WAS 151 MG/DL WITH A DATA FLAG. THE FIRST REPEAT RESULT WAS 318 MG/DL WITH AN INVALIDATING DATA FLAG. THE SECOND REPEAT RESULT USING THE DECREASED MODE WAS 3661 MG/DL. THIS RESULT WAS DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25203750 ↗
• MalfunctionApr 1, 2026Incorrect, Inadequate or Imprecise Result or Readings

  THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED FOR TRIGLYCERIDES ON A COBAS C 303 ANALYTICAL UNIT. THE INITIAL RESULT WAS 456 MG/DL. THE REPEAT RESULT WAS 97.7 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24758025 ↗
• MalfunctionMar 31, 2026Incorrect, Inadequate or Imprecise Result or Readings

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH THE TRIGLYCERIDES ASSAY ON A COBAS C 503 ANALYTICAL UNIT. THE SAMPLE INITIALLY RESULTED IN A TRIGLYCERIDES VALUE OF 682 MG/DL. THE SAMPLE WAS DILUTED 1:5 WITH NACL AND REPEATED, RESULTING IN A TRIGLYCERIDES VALUE OF > 5375 MG/DL WITH A DATA FLAG. THE SAMPLE WAS DILUTED 1:10 WITH NACL AND REPEATED, RESULTING IN A TRIGLYCERIDES VALUE OF 5638 MG/DL. THE SAMPLE WAS REPEATED, RESULTING IN A TRIGLYCERIDES VALUE OF > 950 MG/DL WITH A DATA FLAG. THE SAMPLE WAS DILUTED 1:10 AND REPEATED, RESULTING IN A TRIGLYCERIDES VALUE OF 5682 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24739699 ↗
• MalfunctionFeb 4, 2026Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR TWO PATIENT SAMPLES TESTED WITH TRIGLYCERIDES ON A COBAS C 503 ANALYTICAL UNIT. THE FIRST SAMPLE INITIALLY RESULTED IN A TRIGLYCERIDES VALUE OF 232 MG/DL AND IT REPEATED AS 112 MG/DL. THE SECOND SAMPLE INITIALLY RESULTED IN A TRIGLYCERIDES VALUE OF 234 MG/DL ON (B)(6) 2026 AND IT REPEATED AS 92.1 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24260453 ↗
• MalfunctionNov 14, 2025High Test Results; Material Integrity Problem; High Test Results; Material Integrity Problem

  THERE WAS AN ALLEGATION OF QUESTIONABLE TRIGLYCERIDES RESULTS FOR 2 PATIENT SAMPLES ON A COBAS C 503 ANALYTICAL UNIT. THE CUSTOMER QUESTIONED THE INITIAL RESULTS AS IT DID NOT MATCH THE PATIENTS' PREVIOUS RESULTS WHICH PROMPTED THEM TO REPEAT THE SAMPLES. ON (B)(6) 2025, SAMPLE 1 HAD AN INITIAL RESULT OF 388 MG/DL. THE SAMPLE WAS REPEATED AND THE RESULT WAS 155 MG/DL. THE SAMPLE WAS REPEATED AGAIN ON ANOTHER C503 ANALYZER AND THE RESULT WAS 157 MG/DL. ON (B)(6) 2025, SAMPLE 2 HAD AN INITIAL RESULT OF 212 MG/DL. THE SAMPLE WAS REPEATED TWICE AND THE RESULT WAS 114 MG/DL AND 115 MG/DL. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23556767 ↗
• MalfunctionJul 8, 2025Non Reproducible Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE TRIGLYCERIDES RESULTS FROM THE COBAS C 503 ANALYTICAL UNIT. SAMPLE 1'S INITIAL RESULT WAS 448 MG/DL, THE FIRST REPEAT RESULT WAS 165 MG/DL, AND THE SECOND REPEAT RESULT WAS 163 MG/DL. SAMPLE 2'S INITIAL RESULT ON (B)(6) 2025 WAS 566 MG/DL, THE FIRST REPEAT RESULT WAS 79.2 MG/DL. THE REPEAT RESULTS WERE CONSISTENT WITH THE SAMPLE'S LIPID PROFILE AND THE PATIENT'S MEDICAL HISTORY. THE QUESTIONABLE RESULTS WERE NOT RELEASED OUTSIDE OF THE LABORATORY. IT IS UNCLEAR WHETHER OR NOT THE 2 SAMPLES ARE FROM THE SAME PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22437288 ↗
• MalfunctionMay 23, 2025Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT TRIGLYCERIDES RESULTS FOR ONE PATIENT SAMPLE TESTED ON TWO COBAS C 503 ANALYTICAL UNIT ANALYZERS. THE SAMPLE INITIALLY RESULTED IN A TRIGLYCERIDES VALUE OF 871 MG/DL WHEN TESTED ON THE FIRST C 503 ANALYZER. THE SAMPLE WAS DILUTED 1:10 AND REPEATED ON THE FIRST C 503 ANALYZER, RESULTING IN A VALUE OF 2593 MG/DL. THE SAMPLE WAS REPEATED ON THE SECOND C 503 ANALYZER, RESULTING IN A TRIGLYCERIDES VALUE OF 845 MG/DL. THE SAMPLE WAS DILUTED 1:10 AND REPEATED ON THE SECOND C 503 ANALYZER, RESULTING IN A VALUE OF 2595 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22077666 ↗
• MalfunctionMay 9, 2025Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE TRIGLYCERIDES (TRIGL) ASSAY RESULTS FROM MULTIPLE PATIENT SAMPLES TESTED ON THE COBAS C 503 ANALYTICAL UNIT. THE FOLLOWING ARE EXAMPLES OF DISCREPANT RESULTS: PATIENT SAMPLE 1 ON (B)(6) 2025: THE INITIAL RESULT WAS 2.7 MMOL/L. THE REPEAT RESULT WAS 4.15 MMOL/L. PATIENT SAMPLE 2 ON (B)(6) 2025: THE INITIAL RESULT WAS 2.53 MMOL/L. THE REPEAT RESULT WAS 1.53 MMOL/L. PATIENT SAMPLE 3 ON (B)(6) 2025: THE INITIAL RESULT WAS 3.07 MMOL/L WITH A DATA FLAG. THE REPEAT RESULT WAS 2.03 MMOL/L WITH A DATA FLAG. PATIENT SAMPLE 4 ON (B)(6) 2025: THE INITIAL RESULT WAS 2.07 MMOL/L WITH A DATA FLAG. THE REPEAT RESULT WAS 1.09 MMOL/L WITH A DATA FLAG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21993390 ↗
• MalfunctionApr 4, 2025Incorrect Measurement; Non Reproducible Results; Incorrect Measurement; Non Reproducible Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED WITH TRIGLYCERIDES (TRIGL) ASSAY ON A COBAS C503 ANALYTICAL UNIT. INITIAL RESULT: 721 MG/DL. THE CUSTOMER NOTICED THAT THE INITIAL RESULT WAS HIGH. NO QUESTIONABLE RESULT WAS REPORTED OUTSIDE THE LABORATORY AND THE SAMPLE WAS REPEATED. REPEAT RESULT: 199 MG/DL. THE REPEAT RESULT WAS DEEMED TO BE CORRECT AND REPORTED OUTSIDE THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21774186 ↗
• MalfunctionMar 24, 2025Incorrect Measurement; Non Reproducible Results; Incorrect Measurement; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE TRIGLYCERIDES RESULTS FROM THE COBAS C 303 ANALYTICAL UNIT. SAMPLE (B)(6) INITIAL RESULT WAS 430 MG/DL, AND THE REPEAT RESULT WAS 170 MG/DL. SAMPLE (B)(6) INITIAL RESULT WAS 153 MG/DL, AND THE REPEAT RESULT WAS 253 MG/DL. SAMPLE (B)(6) INITIAL RESULT WAS 154 MG/DL, AND THE REPEAT RESULT WAS 238 MG/DL. SAMPLE (B)(6) INITIAL RESULT WAS 484 MG/DL, AND THE REPEAT RESULT WAS 65.6 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21676357 ↗
• MalfunctionFeb 18, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THERE WAS AN ALLEGATION OF QUESTIONABLE TRIGLYCERIDES RESULTS FOR 1 PATIENT SAMPLE ON A COBAS C 303 ANALYTICAL UNIT. THE INITIAL RESULT WAS 519 MG/DL. THE REPEATED RESULT WAS 371 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21398180 ↗
• MalfunctionFeb 7, 2025High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE TRIGLYCERIDES RESULTS FOR 1 PATIENT SAMPLE ON A COBAS C 503 ANALYTICAL UNIT. THE INITIAL RESULT WAS 295 MG/DL. THE SAMPLE WAS TESTED ON ANOTHER MODULE AND THE RESULT WAS 85.5 MG/DL. THE SAMPLE WAS REPEATED ON THE SAME MODULE AS THE INITIAL RESULT AND THE REPEATED RESULT WAS 87 MG/DL. THE SAMPLE WAS REPEATED AS THE INITIAL RESULT DID NOT MATCH THE PATIENT'S CLINICAL HISTORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21333984 ↗
• MalfunctionNov 14, 2024High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED WITH TRIGLYCERIDES (TRIGL) ASSAY ON A COBAS PURE C303 ANALYTICAL UNIT. INITIAL RESULT: 303 MG/DL. THE CUSTOMER WAS HAVING QC ISSUES AND REPEATED THE SAMPLE. REPEAT RESULT: 235 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20689077 ↗
• MalfunctionJul 24, 2024Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE TRIGLYCERIDES RESULTS FROM SEVEN PATIENT SAMPLES TESTED ON THE COBAS PURE C 303 ANALYTICAL UNIT. THE INITIAL RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY AS THEY DID NOT MATCH THE PATIENTS' MEDICAL HISTORIES. THE REPORTER DEEMED ALL RESULTS INCORRECT. ON (B)(6) 2024: SAMPLE (B)(6). THE INITIAL RESULT WAS 582 MG/DL. THE REPEAT RESULT WAS 374 MG/DL. ON (B)(6) 2024: SAMPLE (B)(6). THE INITIAL RESULT WAS 594 MG/DL. THE REPEAT RESULT WAS 211 MG/DL. ON (B)(6) 2024: SAMPLE (B)(6). THE INITIAL RESULT WAS 609 MG/DL. THE REPEAT RESULT WAS 218 MG/DL. ON (B)(6) 2024: SAMPLE (B)(6). THE INITIAL RESULT WAS 575 MG/DL. THE REPEAT RESULT WAS 255 MG/DL. ON (B)(6) 2024: SAMPLE (B)(6). THE INITIAL RESULT WAS 400 MG/DL. THE REPEAT RESULT WAS 200 MG/DL. ON (B)(6) 2024: SAMPLE (B)(6). THE INITIAL RESULT WAS 553 MG/DL. THE REPEAT RESULT WAS 179 MG/DL. THE FIELD SERVICE REPRESENTATIVE (FSR) INSTRUCTED THE REPORTER TO CHANGE THE REAGENT LOT, CALIBRATE, AND RUN QC. THE ISSUE WAS NOT RESOLVED. ON (B)(6) 2024: SAMPLE (B)(6). THE INITIAL RESULT WAS 553 MG/DL. THE FIRST REPEAT RESULT WAS 280 MG/DL. THE SECOND REPEAT RESULT WAS 181 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19821947 ↗
• MalfunctionJul 11, 2024High Test Results; High Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR TWO PATIENT SAMPLES TESTED WITH TRIGLYCERIDES ON A COBAS C 503 ANALYTICAL UNIT. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE FIRST SAMPLE INITIALLY RESULTED IN A TRIGLYCERIDES VALUE OF 7.37 G/L. THE SAMPLE WAS REPEATED TWICE, RESULTING IN VALUES OF 1.80 G/L AND 1.81 G/L. THE VALUE OF 1.81 G/DL WAS COMMUNICATED TO THE CLINICIAN. THE SECOND SAMPLE INITIALLY RESULTED IN A TRIGLYCERIDES VALUE OF 6.03 G/L. THE SAMPLE WAS REPEATED TWICE, RESULTING IN VALUES OF 1.82 G/L AND 1.81 G/L. THE VALUE OF 1.81 G/DL WAS COMMUNICATED TO THE CLINICIAN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19719599 ↗
• MalfunctionDec 15, 2023High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE TRIGLYCERIDE RESULTS FROM THE COBAS PRO C 503 ANALYTICAL UNIT. PATIENT 1 INITIAL RESULT WAS 438 MG/DL AND THE REPEAT RESULTS WERE 133 MG/DL AND 132 MG/DL. PATIENT 2 INITIAL RESULT WAS 465 MG/DL AND THE REPEAT RESULTS WERE 221 MG/DL AND 224 MG/DL. ON (B)(6) 2023 INI TIAL RESULT WAS 469 MG/DL AND THE REPEAT RESULT WAS 82.3 MG/DL. THE QUESTIONABLE RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18335305 ↗
• MalfunctionDec 8, 2023High Test Results; High Test Results

  THE INITIAL REPORTER RECEIVED A QUESTIONABLE TRIGL TRIGLYCERIDES RESULT FROM ONE PATIENT SAMPLE TESTED ON THE COBAS PRO C 503 ANALYTICAL UNIT. THE INITIAL RESULT WAS 271 MG/DL. THE REPEAT RESULT WAS 129 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18291384 ↗
• MalfunctionMar 3, 2023High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  WE RECEIVED AN ALLEGATION OF QUESTIONABLE RESULTS FOR 1 PATIENT'S SAMPLE TESTED WITH THE TRIGL ASSAY ON COBAS PRO C 503 ANALYTICAL UNIT SERIAL NUMBER (B)(4). ON (B)(6) 2023 AT 8:27 A.M. THE CUSTOMER RAN 1 PATIENT'S SAMPLE AND INITIALLY RESULTED IN TRIGL VALUE OF 266 MG/DL. THE RESULT WAS REPORTED TO THE PHYSICIAN BUT IT DID NOT CORRELATE WITH THE PATIENT'S CLINICAL PICTURE SO HE ASKED TO RETEST THE SAMPLE AGAIN. ON THE SAME DAY AT 10:45 A.M. THE PATIENT'S SAMPLE WAS REPEATED FROM THE SAME PRIMARY TUBE AND ON THE SAME ANALYZER AND RESULTED IN TRIGL VALUE OF 143 MG/DL. LATER IN THE DAY, THE PATIENT'S SAMPLE WAS REPEATED BUT THIS TIME ON ANOTHER C503 MODULE, AND RESULTED IN TRIGL VALUE OF 144 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16479853 ↗
• MalfunctionJan 26, 2023Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 2 PATIENT SAMPLES TESTED FOR EITHER HDL-CHOLESTEROL GEN.4 (HDLC4) OR CHOLESTEROL GEN.2 (CHOL2) ON A COBAS PRO C 503 ANALYTICAL UNIT. PATIENT 1 INITIAL HDLC4 RESULT WAS 4.14 MG/DL. THE REPEAT RESULT WAS 63.6 MG/DL. ON (B)(6) 2023 PATIENT 2 INITIAL CHOL2 RESULT WAS 8.47 MG/DL. THE REPEAT RESULT WAS 195 MG/DL. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE HDLC4 REAGENT LOT NUMBER WAS 63877001 WITH AN EXPIRATION DATE OF 30-APR-2024. THE CHOL2 REAGENT LOT NUMBER WAS 640736 WITH AN EXPIRATION DATE OF 28-FEB-2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16250269 ↗