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

Catalog Number	09230785190
Medical Device Problem Codes	Incorrect Measurement (1383); Low Test Results (2458); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
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.
Additional Manufacturer Narrative
The online tdm methotrexate reagent lot number is 906760, and the expiration date was not provided.A field service engineer (fse) observed no physical discrepancies with the module.The fse performed an instrument check with the reagent pack and the cell check solution.For verification, an instrument check was performed, and the instrument was in normal operation and returned to the customer.The investigation is ongoing.

• 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 46250-0457
• MDR Report Key: 24936944
• Report Number: 1823260-2026-01523
• Device Sequence Number: 5168170
• Product Code: LAO
• UDI-Device Identifier: 07613336224816
• UDI-Public: 07613336224816
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2026

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: 09230785190
• Device Lot Number: 90676001
• 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: 03/29/2026
• Supplement Date Received by Manufacturer: 04/28/2026
• Initial Report FDA Received Date: 04/21/2026
• Supplement Report FDA Received Date: 05/18/2026
• 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