MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ONLINE TDM CARBAMAZEPINE GEN 4; CARBAMAZEPINE ASSAY

Catalog Number 07258135190

Device Problems High Test Results (2457); Device Markings/Labelling Problem (2911)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/22/2022

Event Type  malfunction  

Event Description

The initial reporter received questionable carb4 (carbamazepine) results for one patient tested on a cobas 8000 c 702 module serial number (b)(4).The patient's initial carbamazepine result was reported outside the laboratory.The patient's physician questioned the reported result since the patient does not take the drug.The physician requested the sample to be tested at a different laboratory.The customer sent the patient's sample to a different laboratory to be tested on an unknown analyzer.The patient's carbamazepine result on the c 702 module was 2.1 mg/l.The patient's carbamazepine result at the different laboratory was <0.40 ug/ml.

Manufacturer Narrative

The investigation is ongoing.

Manufacturer Narrative

The analyzer used for testing at the different laboratory was an with attelica.The customer confirmed the negative result, "<0.40" ug/ml, was confirmed with chromatography and spectrometry.The patient's sample was provided for an investigation.The investigation tested the patient's sample and the sample had a levetiracetam concentration of 810 ug/ml and no interference against a component of the reagent was detected.Updated medwatch field: d4 - serial no.

Manufacturer Narrative

Based on the provided information, the investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: ONLINE TDM CARBAMAZEPINE GEN 4
• Type of Device: CARBAMAZEPINE ASSAY
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 14110496
• MDR Text Key: 298796293
• Report Number: 1823260-2022-01041
• Device Sequence Number: 1
• Product Code: KLT
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K151578
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07258135190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: KEPPRA (LEVETIRACETAM); VALPROIC ACID