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

Model Number FT4 G3

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

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

Event Date 10/27/2022

Event Type  malfunction  

Event Description

The initial reporter stated they received a questionable result for one patient sample tested with the elecsys ft4 iii assay on a cobas e 411 immunoassay analyzer.The result did not match the patient's clinical status.The sample resulted in a ft4 value of 1.85 ng/dl (reference range = 1.0 - 1.7 ng/dl) when tested on the e411 analyzer (serial number 8710-12).The value was reported outside of the laboratory and questioned by a doctor.The patient is on medication and has always been under control, so the value did not agree with the patient's history.The doctor asked for repeat testing using a different methodology.A second sample was collected from the patient on (b)(6) 2022 and tested using the abbott architect ft4 method, resulting in a value of 1.39 ng/dl (reference range = 0.70 - 1.48 ng/dl).

Manufacturer Narrative

Calibration and control data were okay.The investigation could not identify a product problem.The differences in values and the recovery in relation to the reference range of the different methods are related to differences in the setups of the assays, the antibodies used, and differences in the standardization materials and procedures used.

• 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: 15844987
• MDR Text Key: 307790678
• Report Number: 1823260-2022-03732
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: EC
• 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: 12/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Model Number: FT4 G3
• Device Catalogue Number: 07976836190
• Device Lot Number: 63723703
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2022
• 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
• Patient Age: 59 YR
• Patient Sex: Female