MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ONLINE TDM CARBAMAZEPINE GEN.4; NEUROLEPTIC DRUGS RADIORECEPTOR ASSAY TEST SYSTEM

Catalog Number	08057435190
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable online tdm carbamazepine gen.4 results with three samples from the same patient tested on a cobas c 503 analytical unit.Sample 1: the sample was tested in a vacuate lithium/heparin tube, and the initial result was 64.9 g/ml.The sample was repeated twice and the results were 24.1 g/ml and 19.6 g/ml.Sample 2: the sample was tested in a vacuette lithium/heparin tube, and the result was 18.1 g/ml.Sample 3: the sample was tested in a vacuette dry/serum, and the result was 17.3 g/ml.
Additional Manufacturer Narrative
The serial number of the analyzer was (b)(6).The investigation is ongoing.
Additional Manufacturer Narrative
Data analysis revealed that the initial (64.9 g/ml) and the first repeat result (24.1 g/ml) were accompanied by data flags that invalidated the results.Regarding the differences in results, the investigation determined that it is likely due to the use of different sample types (tubes) or variations in timing, with possible influences from the preanalytical side (clotting time for the serum sample, filling volume of the different tubes).The investigation did not identify a product problem.

• Brand Name: ONLINE TDM CARBAMAZEPINE GEN.4
• Common Device Name: NEUROLEPTIC DRUGS RADIORECEPTOR ASSAY TEST SYSTEM
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; engelhorngasse 3; wien 1210 ; AU 1210
• Manufacturer Contact: natalie catton ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 23697564
• Report Number: 1823260-2025-04912
• Device Sequence Number: 15734285
• Product Code: KLT
• UDI-Device Identifier: 07613336121108
• UDI-Public: 07613336121108
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K151578
• 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): 01/14/2026

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: 08057435190
• Device Lot Number: 87078301
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/09/2025
• Supplement Date Received by Manufacturer: 12/29/2025
• Initial Report FDA Received Date: 12/02/2025
• Supplement Report FDA Received Date: 01/14/2026
• 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