MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS T4; RADIOIMMUNOASSAY, TOTAL THYROXINE

Catalog Number 09007784188

Device Problems High Test Results (2457); Non Reproducible Results (4029)

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

Event Date 09/10/2023

Event Type  malfunction  

Manufacturer Narrative

The serial number of the e 801 module is (b)(6).Medwatch field e1.Initial reporter email address was provided as (b)(6).

Event Description

The initial reporter stated they received discrepant results for one patient sample tested with elecsys t4 on a cobas e 801 module.No questionable results were reported outside of the laboratory.The sample initially resulted in a t4 value of 303 nmol/l.The result did not match the patient's clinical diagnosis.The sample was repeated, resulting in a t4 value of 155 nmol/l.

Manufacturer Narrative

Calibration and quality control data recovered within expectations.Upon review of the alarm trace, a sample clot was observed on the day of the event.The investigation could not identify a product problem.The cause of the event could not be determined.

• Brand Name: ELECSYS T4
• Type of Device: RADIOIMMUNOASSAY, TOTAL THYROXINE
• 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: 17824013
• MDR Text Key: 324340191
• Report Number: 1823260-2023-03118
• Device Sequence Number: 1
• Product Code: CDX
• Combination Product (y/n): Y
• Reporter Country Code: CH
• PMA/PMN Number: K961490
• 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
• Report Date: 12/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 09007784188
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1