MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ONLINE TDM METHOTREXATE; ENZYME IMMUNOASSAY, METHOTREXATE

Catalog Number	09230815190
Medical Device Problem Codes	Low Test Results (2458); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas c 303 analytical unit serial number is (b)(6).The investigation is ongoing.
Event or Problem Description
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.

• Brand Name: ONLINE TDM METHOTREXATE
• Common Device Name: ENZYME IMMUNOASSAY, METHOTREXATE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• 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: 24807176
• Report Number: 1823260-2026-01326
• Device Sequence Number: 10707718
• Product Code: LAO
• UDI-Device Identifier: 07613336224823
• UDI-Public: 07613336224823
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K233454
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2026

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: 906763
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/17/2026
• Supplement Date Received by Manufacturer: 05/22/2026
• Initial Report FDA Received Date: 04/07/2026
• Supplement Report FDA Received Date: 06/08/2026
• 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