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

Catalog Number 06437281190

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/16/2017

Event Type  malfunction  

Manufacturer Narrative

Unique identifier (udi)#:(b)(4).This event occurred in (b)(6).

Event Description

The customer received questionable elecsys ft3 iii and elecsys ft4 ii assay result for two patient samples from a cobas 8000 e 602 module.The serial number was requested but was not provided.The samples were investigated using a cobas 8000 e 801 module, cobas 6000 e 601 module, and a cobas e 411 immunoassay analyzer.Refer to the attachment to the medwatch for all patient data.Information concerning if any erroneous results was reported outside of the laboratory was requested, but it was unknown.There was no allegation of an adverse event.Refer to the medwatch with patient identifier (b)(6) for the other assay.

Manufacturer Narrative

Sample from the patient was submitted for investigation and an interfering factor to a reagent component was found which affected the results.This interference is documented in product labeling for the assay.The incidence rate of the identified interfering factor is monitored on a quarterly basis.

Manufacturer Narrative

An additional sample from the patient was submitted for investigation of an interfering factor.No interfering factor was found in the patient sample.

Manufacturer Narrative

A new sample obtained on (b)(6) 2020 for patient originally labeled with id (b)(6) was submitted for investigation of an interfering factor.No interfering factor was found in the patient sample.

• Brand Name: FT4, FREE THYROXINE
• 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: 7078856
• MDR Text Key: 94485039
• Report Number: 1823260-2017-02817
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K961489
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/14/2020

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 Catalogue Number: 06437281190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/16/2017
• Initial Date FDA Received: 12/04/2017
• Supplement Dates Manufacturer Received: 11/16/2017; 11/16/2017; 11/16/2017
• Supplement Dates FDA Received: 12/19/2017; 06/26/2020; 10/14/2020
• 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
• Type of Device Usage: N
• Patient Sequence Number: 1