ONLINE TDM Methotrexate 09230785190Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613336224816), received between Apr 3, 2024 and Apr 21, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “High Test Results” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 21, 2026Incorrect Measurement; Low Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE ONLINE TDM METHOTREXATE RESULT FROM THE COBAS 6000 C (501) MODULE FOR ONE PATIENT. THE INITIAL RESULT WAS 1.215 UMOL/L, ACCOMPANIED BY A DATA FLAG. THE SAMPLE WAS THEN AUTO DILUTED 1:14 WITH A RESULT OF 16.012 UMOL/L. ON (B)(6) 2026 THE SAMPLE WAS REPEATED MULTIPLE TIMES. THE FIRST RESULT WAS 1.278 UMOL/L, ACCOMPANIED BY A DATA FLAG. THE AUTO-DILUTED RESULT WAS 17.548 UMOL/L, ACCOMPANIED BY A DATA FLAG. THE SAMPLE WAS DILUTED 1:50 WITH RESULTS OF 62.494 UMOL/L AND 62.643 UMOL/L, BOTH ACCOMPANIED BY A DATA FLAG. THE SAMPLE WAS DILUTED 1:200 WITH RESULTS OF 1.273 UMOL/L, ACCOMPANIED BY A DATA FLAG AND 3.627 UMOL/L. ANOTHER REPEAT RESULT AFTER A DILUTION OF 1:200 WAS 725.4 UMOL/L. THE DOCTOR WAS EXPECTING A RESULT OF >600 UMOL/L AND ASKED FOR THE SAMPLE TO BE REPEATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24936944 ↗
• MalfunctionApr 3, 2024High Test Results; No Apparent Adverse Event; High Test Results; No Apparent Adverse Event

  THERE WAS AN ALLEGATION OF QUESTIONABLE METHOTREXATE (MTX) RESULTS FROM THE COBAS 8000 COBAS C 502 MODULE. THE INITIAL TEST GAVE NO NUMERIC RESULT BUT HAD A DATA FLAG INDICATING THE RESULT WAS GREATER THAN THE TEST RANGE. THE REPEAT RESULT WITH A 1:10 DILUTION GAVE NO NUMERIC RESULT BUT HAD A DATA FLAG INDICATING THE RESULT WAS GREATER THAN THE TEST RANGE. THE CUSTOMER REPEATED THE SAMPLE WITH A 1:100 MANUAL DILUTION AND THE RESULT WAS 218 UMOL/L. THE NEAT SAMPLE AND THE 1:10 DILUTION SAMPLE WERE TESTED ON ANOTHER ANALYZER AND GAVE NO NUMERIC RESULT BUT HAD A DATA FLAG INDICATING THE RESULT WAS GREATER THAN THE TEST RANGE. ON THE OTHER ANALYZER, THE CUSTOMER REPEATED THE SAMPLE WITH A 1:100 MANUAL DILUTION AND THE RESULT WAS 110 UMOL/L. THE QUESTIONABLE RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THE REPEAT RESULT WAS BELIEVED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19032525 ↗