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 07/19/2016

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer stated that they received questionable results for one patient sample tested for free triiodothyronine (ft3) and free thyroxine (ft4) on an e602 analyzer.A sample interference is suspected.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 the e602 analyzer and the initial results were reported outside of the laboratory.The sample was provided for investigation where it was tested on an e170 analyzer and an e411 analyzer.Refer to the attachment for the sample 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 was serial number (b)(4).Ft4 reagent lot number 140865, with an expiration date of march 2017 was used on this analyzer.The e411 analyzer used for investigation was serial number (b)(4).Ft4 reagent lot number 140865, with an expiration date of march 2017 was used on this analyzer.

Manufacturer Narrative

A sample from the patient was provided for investigation.Investigations of the sample determined that it contains an interferent to the streptavidin used in the ft4 reagent.This limitation is covered in product labeling.No interfering factor to the assay antibody/idiotype was identified.

• 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: 5884093
• MDR Text Key: 52509524
• Report Number: 1823260-2016-01227
• 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
• Type of Report: Initial,Followup
• Report Date: 08/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2016
• 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?: No
• Date Manufacturer Received: 07/22/2016
• 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