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	03/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas c503 analytical unit serial number was (b)(6).The calibration was last performed on 03-mar-2025 and it was acceptable.The qc recovery before and after the event was within specifications.The alarm trace showed sample clot detection, sample probe: sample short, and sample short s1 alarms.These are indicators of possible poor sample quality.The field service engineer found the instrument and the reagent were performing within specifications.A hardware performance check, precision studies, and qc were performed and they were all within specifications.The patient sample was re-tested on (b)(6) 2025 with an mtx result of 0.533 umol/l (considered acceptable).The investigation is ongoing.
Event or Problem Description
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.
Additional Manufacturer Narrative
No further issues were reported after the service visit.The investigation did not identify a product problem.The cause of the event could not be determined.

• 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: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 21761673
• Report Number: 1823260-2025-00996
• Device Sequence Number: 18265381
• Product Code: LAO
• UDI-Device Identifier: 07613336224823
• UDI-Public: 07613336224823
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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): 05/05/2025

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 Expiration Date: 09/30/2025
• Device Catalogue Number: 09230815190
• Device Lot Number: 85040901
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/12/2025
• Supplement Date Received by Manufacturer: 04/23/2025
• Initial Report FDA Received Date: 04/03/2025
• Supplement Report FDA Received Date: 05/05/2025
• 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 Age: 17 YR
• Patient Sex: Female