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

Catalog Number 09043276190

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Low Test Results (2458); Non Reproducible Results (4029)

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

Event Date 11/23/2023

Event Type  malfunction  

Manufacturer Narrative

The core unit serial number was (b)(6).

Event Description

The initial reporter complained of discrepant results for 1 patient sample tested for elecsys ft4 iv (ft4 iv) on a cobas 6000 core unit.The initial result was 1.02 ng/dl.The repeat result was 3.68 ng/dl.

Manufacturer Narrative

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

• 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: 18327173
• MDR Text Key: 330975821
• Report Number: 1823260-2023-03998
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): Y
• Reporter Country Code: TC
• 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: 02/02/2024

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: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2024
• 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