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 09/14/2017

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).(b)(4).

Event Description

The customer stated that they received erroneous results for one patient sample tested for elecsys ft3 iii and the elecsys ft4 ii assay (ft4) on a cobas 8000 e 602 module (e602).It was asked, but it is not known if erroneous results were reported outside of the laboratory.This medwatch will apply to the ft4 assay.Please refer to the medwatch with patient identifier (b)(4) for information related to the ft3 assay.The sample was tested on the customer's e602 analyzer and also on an aia-cl1200 analyzer.The sample was provided for investigation, where it was tested on an e602 analyzer and a cobas e 411 immunoassay analyzer (e411).No adverse events were alleged to have occurred with the patient.The serial number of the e602 analyzer used at the customer site was asked for, but not provided.The serial number of the e602 analyzer used for investigation was requested, but not provided.Ft4 reagent lot number 246825, with an expiration date of june 2018 was used on this analyzer.The serial number of the e411 analyzer used for investigation was (b)(4).Ft4 reagent lot number (b)(4), with an expiration date of march 2018 was used on this analyzer.

Manufacturer Narrative

The patient sample was provided for investigation.The sample was checked for possible interfering factors, but no interfering factor was identified.There was not enough remaining volume of the sample available for further investigation.For diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination and other findings,.

Manufacturer Narrative

A new sample from the same patient was collected and provided for investigation.For the investigation, the sample was tested on an e602 analyzer and e411 analyzer on 15-jan-2017.Refer to the attachment for all test data.It was asked, but it is not known if any erroneous results from this sample were reported outside of the laboratory.No adverse events were alleged to have occurred with the patient.The serial number of the e602 analyzer used for investigation of this new sample was (b)(4).Ft4 reagent lot number 270341, with an expiration date of 30-nov-2018 was used on this analyzer.The serial number of the e411 analyzer used for investigation of this new sample was (b)(4).Ft4 reagent lot number 265631, with an expiration date of 30-sep-2018 was used on this analyzer.

Manufacturer Narrative

Upon further investigations of the new sample, it was determined that it contains a factor which interferes with a component of the ft4 assay.This limitation is covered in product labeling.

• 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: 6934767
• MDR Text Key: 90395118
• Report Number: 1823260-2017-02238
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2018
• Device Catalogue Number: 06437281190
• Device Lot Number: 246825-031
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/21/2017
• 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
• Patient Age: 80 YR