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

Catalog Number	04491041190
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	04/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The c501 module serial number was (b)(6).The calibration was last performed on (b)(6) 2025, and it was acceptable.Qc was within the ranges on the day of the event.The alarm trace did not show any abnormalities.The investigation is ongoing.
Event or Problem Description
We received an allegation about discrepant results for 1 patient sample tested with online tdm valproic acid (valp2) assay on a cobas 6000 c501 module.Initial result: 0.9 ug/ml (accompanied by a data flag).1st repeat result: 88.4 ug/ml.The 2nd repeat result matched the 1st repeat result.
Additional Manufacturer Narrative
The customer alleged discrepant valp2 results for an additional patient sample tested on (b)(6) 2025: initial result: 0.4 ug/ml (accompanied by a data flag).1st repeat result: 72.7 ug/ml.2nd repeat result: 75.3 ug/ml.The field service engineer replaced the seals on the reagent pipette transport mechanism, the sample pipette, and 2 reagent pipettes.He also replaced the syringe mechanisms and pipes, including the detergent riser.The preventive maintenance was last performed in feb-2025.The investigation is ongoing.
Additional Manufacturer Narrative
Based on the provided data, a general lot-specific reagent issue can be excluded since calibration and qc were acceptable.After several service actions were performed by the field service engineer, the analyzer performed within specifications for a month, then the issue reoccurred.The customer could not provide additional pre-analytical data for further investigation because the samples arrived centrifuged and collected in a secondary tube at the laboratory for processing.The investigation did not identify a product problem.The cause of the event was consistent with a preanalytic issue (since the result is almost zero) at the customer site.Preanalytics are within the customer's responsibility.

• 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: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 21967140
• Report Number: 1823260-2025-01388
• Device Sequence Number: 15486639
• Product Code: LEG
• UDI-Device Identifier: 04015630998913
• UDI-Public: 04015630998913
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/21/2025

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: 04491041190
• Device Lot Number: 789658
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/11/2025
• Supplement Date Received by Manufacturer: 06/03/2025; 06/27/2025
• Initial Report FDA Received Date: 05/06/2025
• Supplement Report FDA Received Date: 06/25/2025; 07/21/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: VALPROIC ACID: 6ML SUSPENSION OF 4G/100ML
• Patient Sex: Female