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 07/31/2015

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer questioned results from 3 patient samples tested for thyrotropin (tsh), free thyroxine (ft4) and free triiodothyronine (ft3).The customer provided data for the 3 patient samples for investigation.Of the data provided, erroneous tsh, ft4 and ft3 results were identified for 1 patient sample 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.All results from the investigation will be reported to the customer.This medwatch will cover ft4.Refer to medwatch with patient identifier (b)(6) for information on the ft3 erroneous results and medwatch with patient identifier (b)(6) for information on the tsh erroneous results.Refer to the attached data for patient results.No adverse event was reported.The e 170 analyzer serial number was 1519-01.The e411 analyzer serial number was (b)(4).The ft4 reagent lot number used with the e170 analyzer at the investigation site was 180539 with an expiration date of 10/31/2015.The ft4 reagent lot number used with the e411 analyzer at the investigation site was 183473 with an expiration date of 01/31/2016.The serial number for the customer's e602 analyzer is not known.

Manufacturer Narrative

The patient sample was submitted for investigation.During investigation the customer's ft4 results were reproduced.

• 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) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 5015325
• MDR Text Key: 25495315
• Report Number: 1823260-2015-03991
• 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: Followup
• Report Date: 09/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2015
• 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
• Date Manufacturer Received: 08/03/2015
• 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
• Type of Device Usage: N
• Patient Sequence Number: 1