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 07/02/2015

Event Type  malfunction  

Event Description

The customer questioned results from 1 patient sample tested for thyrotropin (tsh), free thyroxine (ft4) and free triiodothyronine (ft3).The customer provided the sample for investigation.During the investigation, erroneous ft4 results were identified between the customer's e602 analyzer, a centaur analyzer, an e 170 analyzer used at the investigation site and an e411 analyzer used at the investigation site.The date of tests performed at the customer site is not known.It is not known if erroneous results were reported outside of the laboratory.Refer to the attached data for patient results.No adverse event was reported.The e 170 analyzer serial number was (b)(4).The e411 analyzer serial number was (b)(4).The ft4 reagent lot number used with the e170 analyzer at the investigation site was 183473 with an expiration date of 01/31/2016.The ft4 reagent lot number used with the e411 analyzer at the investigation site was 181732 with an expiration date of 01/31/2016.The serial number for the customer's e602 analyzer is not known.A specific root cause could not be identified.Based on the available data, a general reagent issue could be excluded.When comparing values from different types of analyzers, variances can be expected.For thyroid parameters, age, gender and other patient characteristics should be considered when comparing values.

Manufacturer Narrative

This event occurred in (b)(6).

• Brand Name: FT4, FREE THYROXINE
• Type of Device: RADIOIMMUNOASSAY, FREE THYROXINE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 6830 5; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 4936409
• MDR Text Key: 6434450
• Report Number: 1823260-2015-03854
• 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,User Facility
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 07/23/2015

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
• Is the Reporter a Health Professional?: Yes
• Event Location: Laboratory
• Initial Date Manufacturer Received: 07/06/2015
• Initial Date FDA Received: 07/23/2015
• 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
• Patient Sequence Number: 1