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

Catalog Number	04491041190
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable online tdm valproic acid results for 1 patient sample on a cobas 8000 cobas c 502 module.The initial result was 4.2 g/ml.The result was questioned by the physician, and the sample was repeated.The repeated results were 184.3 g/ml and 109.5 g/ml.A dilution was performed, and the result was 219 g/ml.This result was believed to be correct.The customer indicated that the sample quality was in question.
Additional Manufacturer Narrative
The analyzer's serial number is (b)(6).The customer declined a service visit because repeated results for all other valproic acid samples, which were tested the previous week, were acceptable and matched the original results.A sample quality issue is suspected.The investigation is ongoing.
Additional Manufacturer Narrative
The investigation determined the issue was consistent with a pre-analytical handling issue.The investigation did not identify a specific cause of the event.

• Brand Name: ONLINE TDM VALPROIC ACID
• Common Device Name: ENZYME IMMUNOASSAY, VALPROIC ACID
• 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: 23453205
• Report Number: 1823260-2025-04462
• Device Sequence Number: 9318474
• Product Code: LEG
• UDI-Device Identifier: 04015630998913
• UDI-Public: 04015630998913
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K060690
• 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): 12/01/2025

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 Catalogue Number: 04491041190
• Device Lot Number: 815184
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/09/2025
• Supplement Date Received by Manufacturer: 11/06/2025
• Initial Report FDA Received Date: 11/03/2025
• Supplement Report FDA Received Date: 12/01/2025
• 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 Sex: Unknown