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 09/13/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported that they received erroneous results for one patient sample tested for elecsys ft3 iii (ft3) and the elecsys ft4 ii assay (ft4) on an e602 analyzer.This medwatch will cover ft4.Patient identifier (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 stated that the initial results at the customer site are automatically 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.The e170 analyzer used for investigation purposes was serial number (b)(4).The ft4 reagent lot number used on this analyzer was 168540, with an expiration date of july 2017.The e411 analyzer used for investigation purposes was serial number (b)(4).The ft4 reagent lot number used on this analyzer was 140865, with an expiration date of march 2017.A specific root cause could not be determined based on the provided information.There was not enough sample volume remaining for further investigation.A general reagent issue could not be detected.A biological component may be present in the sample that would interact differently with the assay components during the pre-wash procedure.The customer's e602 analyzer and the e170 analyzer use the pre-wash procedure.The e411 analyzer does not use the pre-wash procedure, so this may result in discrepant results when compared to the analyzers using the pre-wash procedure.

• 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: 5980680
• MDR Text Key: 55794944
• Report Number: 1823260-2016-01476
• 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
• Report Date: 09/27/2016

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: ASKU
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/16/2016
• Initial Date FDA Received: 09/27/2016
• 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