MAUDE Adverse Event Report: ROCHE DIAGNOSTICS VALP2; ENZYME IMMUNOASSAY, VALPROIC ACID

Catalog Number	05108438190
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2020
Type of Reportable Event	Malfunction
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 8000 cobas c502 module.Initial result: <5 mg/l.The physician questioned the result and requested a repeat of the sample since he suspected an intentional drug intoxication.Repeat result: 974 mg/l (after dilution 1:10).
Additional Manufacturer Narrative
The cobas c502 serial number was (b)(6).The customer asked if valp2 assay can be affected by a hook effect.The investigation is ongoing.
Additional Manufacturer Narrative
The customer is not able to provide the calibration traces and the qc values for the date of the event and the sample was not available for investigation.The sample was diluted with the pstdm1-diluent.Valp is an emit enzyme immunoassay technique assay, and therefore due to the technique used, it is not affected by the hook (heidelberg curve) effect.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: VALP2
• 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: 19741124
• Report Number: 1823260-2024-02023
• Device Sequence Number: 3654086
• Product Code: LEG
• UDI-Device Identifier: 04015630999385
• UDI-Public: 04015630999385
• Combination Product (Y/N): Y
• Initial Reporter Country: FR
• 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
• Report Date (Section B): 08/07/2024

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: 12/31/2024
• Device Catalogue Number: 05108438190
• Device Lot Number: 75028001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/21/2024
• Supplement Date Received by Manufacturer: 08/05/2024
• Initial Report FDA Received Date: 07/15/2024
• Supplement Report FDA Received Date: 08/07/2024
• 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