ONLINE TDM Methotrexate 09230815190Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613336224823), received between Apr 3, 2025 and Sep 9, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Low 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2026Non Reproducible Results

  The initial reporter received questionable ONLINE TDM Methotrexate assay results for several patient samples tested on the cobas c 503 analytical unit and the cobas pure c 303 analyzer.The following are examples of discrepant results for 3 patients from the list provided:PATIENT 1Sample AOn (b)(6) 2026:The initial result was 1.21 umol/L with a data flag.The repeat result was 60.5 umol/L with a data flag.Sample BOn (b)(6) 2026:The initial result was 1.21 umol/L with a data flag.The repeat result at reduced sample volume was 16.8 umol/L.Sample COn (b)(6) 2026:Results from the c 503 analyzer:The initial result was 1.21 umol/L.The repeat result in reduced sample volume was 16.8 umol/L.This patient sample was rerun on a Cobas Pure analyzer:The repeat results of a manual 3-fold dilution and an automated 5-fold dilution were approximately 96.3 µmol/L.Repeat results of 32.1 umol/L and 19.1 umol/L were also provided.On (b)(6) 2026:The repeat result at a dilution ratio of 50 was >60 umol/L.The repeat result at a manual dilution ratio of 50 was 92 umol/L.Sample DThe result at a manual dilution ratio of 50 was 63.3 umol/L.PATIENT 2Sample AOn (b)(6) 2026:The initial result was 1.21 umol/L with

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50695561 ↗
• MalfunctionJul 28, 2026Low Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50052249 ↗
• MalfunctionApr 7, 2026Low Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE ONLINE TDM METHOTREXATE RESULT FROM THE COBAS C 303 ANALYTICAL UNIT FOR TWO PATIENTS. PATIENT 1'S INITIAL RESULT WITH THE PATIENT SAMPLE AT A 1:10 DILUTION WAS 3.31 UMOL/L, AND THE REPEAT RESULT WAS 1.25 UMOL/L, ACCOMPANIED BY A DATA FLAG. PATIENT 2'S INITIAL RESULT ON (B)(6) 2026 WAS 1.18 UMOL/L. THE FIRST REPEAT RESULT WITH THE PATIENT SAMPLE AT 1:10 DILUTION WAS 4.32 UMOL/L. THE SECOND REPEAT RESULT USING THE DECREASED OPTION WAS 4.37 UMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24807176 ↗
• MalfunctionApr 3, 2025Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED WITH ONLINE TDM METHOTREXATE (MTX) ASSAY ON A COBAS C503 ANALYTICAL UNIT. INITIAL RESULT: 0.04 UMOL/L (ACCOMPANIED BY A DATA FLAG). THE PROVIDER QUESTIONED THE INITIAL RESULT SINCE IT WAS LOW AND THE SAMPLE WAS THEN REPEATED. REPEAT RESULT: 0.49 UMOL/L (TESTED ON A COBAS C303). THE REPEAT RESULT WAS DEEMED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21761673 ↗