MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ONLINE TDM PHENYTOIN - FREE PHENYTOIN APPLICATION; DIPHENYLHYDANTOIN ENZYME IMMUNOASSAY

Catalog Number	08445567190
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the c 503 analyzer is (b)(6), the investigation is ongoing.
Event or Problem Description
The initial reporter stated they received discrepant results for 12 patient samples tested with online tdm phenytoin - free phenytoin application on a cobas c 503 analytical unit.Please refer to the attachment for all patient data.
Additional Manufacturer Narrative
Medwatch fields d1, d2, d4, g1, and g4 have been updated.

• Brand Name: ONLINE TDM PHENYTOIN - FREE PHENYTOIN APPLICATION
• Common Device Name: DIPHENYLHYDANTOIN ENZYME IMMUNOASSAY
• 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: 24455671
• Report Number: 1823260-2026-00708
• Device Sequence Number: 18654855
• Product Code: DIP
• UDI-Device Identifier: 07613336157787
• UDI-Public: 07613336157787
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K030428
• 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,Followup
• Report Date (Section B): 06/03/2026

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: 08445567190
• Device Lot Number: 89604701
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/10/2026
• Supplement Date Received by Manufacturer: 02/26/2026; 05/19/2026
• Initial Report FDA Received Date: 02/26/2026
• Supplement Report FDA Received Date: 03/23/2026; 06/03/2026
• 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