MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS FT4 III; RADIOIMMUNOASSAY, FREE THYROXINE

Model Number FT4 G3

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 03/01/2023

Event Type  malfunction  

Event Description

The initial reporter stated they received discrepant results for one patient sample tested with the elecsys ft4 iii assay on cobas 6000 e601 module serial number (b)(4).The patient sample resulted in a ft4 value of 30.670 when tested on the e601 analyzer.The sample was repeated using the abbott ft4 method, resulting in a value of around 19 pmol/l.

Manufacturer Narrative

Initial reporter phone number was provided as (b)(6).

Manufacturer Narrative

The ft4 value measured with the roche assay was above the normal reference range of the assay (12 - 22 pmol/l).The ft4 value measured with the abbott assay was as the high end of the normal reference range for that assay (9 - 19 pmol/l).The ft4 value measured with the roche assay is most likely the correct value.The investigation could not identify a product problem.

• Brand Name: ELECSYS FT4 III
• Type of Device: RADIOIMMUNOASSAY, FREE THYROXINE
• 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: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 16657603
• MDR Text Key: 312542153
• Report Number: 1823260-2023-01047
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: MU
• PMA/PMN Number: K131244
• 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: 04/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Model Number: FT4 G3
• Device Catalogue Number: 07976836190
• Device Lot Number: 67527900
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/13/2023
• Initial Date FDA Received: 03/31/2023
• Supplement Dates Manufacturer Received: 04/05/2023
• Supplement Dates FDA Received: 04/10/2023
• 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