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

Catalog Number ASKU

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/09/2016

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer stated that they received erroneous results for one patient sample tested for free triiodothyronine (ft3) and free thyroxine (ft4) on an e602 analyzer.This medwatch will cover ft4.Please refer to the medwatch with patient identifier (b)(6) for information related to ft3.The sample was initially tested at the customer site on an e602 analyzer and these initial ft3 and ft4 results were reported outside of the laboratory.The sample was provided for investigation where it was tested for ft3 and ft4 on an e170 analyzer on (b)(6) 2016 and an e411 analyzer on (b)(6) 2016.Refer to the attachment for the result data.The patient was not adversely affected.The serial number of the e602 analyzer used at the customer site was asked for, but not provided.The e170 analyzer used for investigation purposes was 1519-01.Ft4 reagent lot number 188609, with an expiration date of october 2016 was used on this analyzer.The e411 analyzer used for investigation purposes was 0600-12.Ft4 reagent lot number 188609, with an expiration date of october 2016 was used on this analyzer.

Manufacturer Narrative

A specific root cause could not be determined based on the provided information.There was no remaining volume of the patient sample available for further investigations.

• 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: 5625066
• MDR Text Key: 44385143
• Report Number: 1823260-2016-00569
• 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
• Report Date: 05/09/2016

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: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/15/2016
• Initial Date FDA Received: 05/03/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/09/2016
• 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