MAUDE Adverse Event Report: Roche Diagnostics ONLINE TDM Methotrexate; Enzyme immunoassay, methotrexate

Catalog Number	09230815190
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2026
Type of Reportable Event	Malfunction
Event or Problem Description
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 1 sample a on (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 b on (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 c on (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 d the result at a manual dilution ratio of 50 was 63.3 umol/l.Patient 2 sample a on (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.The repeat result was 58.6 umol/l with a data flag.Sample b on (b)(6) 2026: the initial result was 1.20 umol/l.The first repeat result was 1.20 umol/l with a data flag.The second repeat result in reduced sample volume was 16.7 umol/l.On (b)(6) 2026: the third repeat result was 1.2 umol/l the fourth repeat result at a dilution ratio of 50 was 58.9 umol/l with a data flag.-- the fifth repeat result at a dilution ratio of 150 was 75.9 umol/l.Sample c the result at a dilution ratio of 50 was >60 umol/l.Patient 3 sample a on (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 b on (b)(6) 2026: the initial result was 1.18 umol/l.The first repeat result in reduced sample volume was 16 umol/l.The second repeat result in reduced sample volume was 16 umol/l.The third repeat result at a dilution ratio of 50 was 15.7 umol/l with a data flag.
Additional Manufacturer Narrative
The cobas c 503 analytical unit serial number is (b)(6).The cobas pure c 303 analyzer serial number and the online tdm methotrexate reagent lot number used for this analyzer were not provided.

• Brand Name: ONLINE TDM Methotrexate
• Common Device Name: Enzyme immunoassay, methotrexate
• Manufacturer (Section D): Roche Diagnostics; 9115 hague road; indianapolis IN 46250 -045
• Manufacturer (Section G): Roche Diagnostics GmbH; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: natalie catton ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 50695561
• Report Number: 1823260-2026-03678
• Device Sequence Number: 18563238
• Product Code: LAO
• UDI-Device Identifier: 07613336224823
• UDI-Public: 07613336224823
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K233454
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/09/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 09230815190
• Device Lot Number: 90676301
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/13/2026
• Initial Report FDA Received Date: 09/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown