MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS FT4 IV; FREE THYROXINE

Catalog Number 09043276190

Device Problem Non Reproducible Results (4029)

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

Event Date 11/17/2023

Event Type  malfunction  

Event Description

There was an allegation of a questionable ft4 g4 elecsys result from the cobas e411 rack analyzer.The ft4 result from the cobas e411 rack was 2.14 ng/dl.The result from a siemens analyzer was 1.64 ng/dl.

Manufacturer Narrative

The cobas e411 rack serial number was (b)(6).The investigation is ongoing.

Manufacturer Narrative

Sample from the patient was not available for further investigation.From the information provided and the analysis thereof, a general reagent issue could most likely be excluded.The differences generated between the different methods most likely relate to normal methodological differences.Assays from different vendors can generate different values.This relates to the overall setups of the assays, the antibodies used, and differences in reference materials/methods and the standardization methodology used.

• Brand Name: ELECSYS FT4 IV
• Type of Device: FREE 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: 18329195
• MDR Text Key: 330969674
• Report Number: 1823260-2023-04013
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): Y
• Reporter Country Code: SP
• PMA/PMN Number: K220456
• 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: 01/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 09043276190
• Device Lot Number: 72489601
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/15/2024
• 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