MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ONLINE TDM CARBAMAZEPINE GEN.4; CARBAMAZEPINE ENZYME IMMUNOASSAY

Model Number CARB G4

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/24/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation believes there is an interferent present affecting the carb4 results from the cobas c501.The patient samples were provided for further investigation.The investigation is currently ongoing.The event occurred in: (b)(6).

Event Description

The initial reporter complained of questionable carb4 carbamazepine results for 1 patient tested on a cobas 6000 c (501) module compared to the carb carbamazepine result from a cobas integra 400 plus.The initial reporter believes the carb4 results are not matching the treatment of the patient.The initial carb4 result from the cobas c501 for a patient under carbamezepine treatment was < 2.00 ug/ml with a data flag.On (b)(6) 2019 the physician took samples both before and after treatment and the carb4 results from the cobas c501 were < 2.00 ug/ml with a data flag and < 2.00 ug/ml with a data flag.The patient samples were sent to another site and tested on a integra 400.The carb results were positive for the samples collected after treatment.The specific results were not provided.The cobas c501 serial number is (b)(4).

Manufacturer Narrative

Section d4, expiration date was updated.The patient sample was submitted for investigation.The customer's observation was confirmed.An interfering substance within the sample is suspected as the reaction kinetics were faster compared to an analyte free sample.The interfering substance had a molecular weight of > 100 kd.An interference by gammopathy could not be excluded as gammopathy does not necessarily mean a higher immunoglobulin concentration.Product labeling states: "in very rare cases, gammopathy, in particular type igm (waldenstrom's macroglobulinemia), may cause unreliable results." a product problem was not found.

• Brand Name: ONLINE TDM CARBAMAZEPINE GEN.4
• Type of Device: CARBAMAZEPINE ENZYME IMMUNOASSAY
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 8868703
• MDR Text Key: 153824434
• Report Number: 1823260-2019-02868
• Device Sequence Number: 1
• Product Code: KLT
• Combination Product (y/n): N
• PMA/PMN Number: K151578
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 03/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Model Number: CARB G4
• Device Catalogue Number: 07258062190
• Device Lot Number: 364239
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARMAMAZEPINE