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 Consequences Or Impact To Patient (2199)

Event Date 12/07/2015

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer reported that they received erroneous results for one patient sample tested for free triiodothyronine (ft3) and free thyroxine (ft4).This medwatch will cover ft4.Refer to the medwatch with (b)(6) for information referring to ft3.The sample was initially tested at the customer site on an e602 analyzer.During investigations, the patient sample was tested on an e170 analyzer and an e411 analyzer.Refer to the attachment for the specific patient result values.It was asked, but it is unknown which patient results, if any, were reported outside of the laboratory.The patient was not adversely affected.The e602 analyzer serial number used at the customer site was asked for, but not provided.

Manufacturer Narrative

A specific root cause could not be determined based on the provided information.There was not sufficient sample available for further investigations.A general reagent issue could not be detected.

Manufacturer Narrative

A new sample from the patient has been provided for investigation.This sample resulted as 1.20 uiu/ml for tsh, 5.0 pg/ml for ft3, 1.82 ng/dl for ft4, and 3.7 iu/l for anti-tshr when tested on the customer's e602 analyzer.

Manufacturer Narrative

With regards to investigation of the new patient sample, investigations of the sample determined that it contains an interfering factor to the streptavidin used in the ft3 and ft4 reagents.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: 5320470
• MDR Text Key: 34177289
• Report Number: 1823260-2015-06095
• 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: 03/17/2016

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: 06437281190
• Device Lot Number: 184927
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/07/2015
• Initial Date FDA Received: 12/22/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 01/08/2016; 03/01/2016; 03/17/2016
• 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