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

Model Number FT4 G3

Device Problem Incorrect Measurement (1383)

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

Event Date 04/22/2021

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).Unique device identifier (udi) (b)(4).The customer's calibration and qc results, system alarm trace, and sample pre-analytical details were requested but not provided.The patient's sample was requested for further investigation, but not enough sample remained for further investigation.Based on the available information, the investigation did not identify a product problem.The cause of the event could not be determined.

Event Description

The initial reporter received questionable elecsys ft4 iii assay and elecsys ft3 iii results for one patient tested on a cobas 8000 e 801 module serial number (b)(4).The customer reported out the results to a physician who asked for re-measurement of the sample.The customer provided the patient's sample for an investigation and the sample was tested on a cobas 8000 e 801 module.Also, the sample was tested on an outsourced abbott architect analyzer.This medwatch is for ft4.Refer to the medwatch with patient identifier (b)(6) for the ft3 assay.

• Brand Name: ELECSYS FT4 III ASSAY
• 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: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 11937842
• MDR Text Key: 254243623
• Report Number: 1823260-2021-01653
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K131244
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/04/2021

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: 01/31/2022
• Device Model Number: FT4 G3
• Device Catalogue Number: 07976887190
• Device Lot Number: 520701
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/17/2021
• Initial Date FDA Received: 06/04/2021
• 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: 46 YR