MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XP FT4; RADIOIMMUNOASSAY, FREE THYROXINE

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/07/2016

Event Type  malfunction  

Manufacturer Narrative

The cause for the lower (normal) advia centaur xp ft4 results compared to higher (above normal) ft4 results tested at sister facility on a different ft4 test method is unknown.The customer's quality control results were within acceptable ranges.There were no related errors observed in system event log, and no other assay testing issues at the time of the event.The physician(s) was expecting a normal ft4 result based on clinical evidence, however it is uncertain which ft4 test method results are considered discordant.Siemens in investigating.The instruction for use (ifu) under the interpretation of results section states the following: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings.".

Event Description

Low advia centaur xp ft4 results were obtained by the customer and considered discordant compared to higher ft4 results tested at sister facility on a different ft4 test method.The patient was originally tested at the customer's site in (b)(6) 2016 and the ft4 result was normal on an alternate test method.The patient was redrawn, tested in (b)(6) 2016 at the same sister site, and the ft4 result was elevated.The following month ((b)(6) 2016) the patient was redrawn, tested on the advia centaur xp by this customer, and the ft4 result was lower.The patient was redrawn and tested in (b)(6) 2017 at the sister site and the ft4 result was elevated on an alternate test method.The patient was redrawn, tested on the advia centaur xp by this customer in (b)(6) 2017, and the ft4 result was lower, and a delay in result reporting.Patient treatment was not prescribed or altered.There was no report of adverse health consequences due to the lower ft4 results.

Manufacturer Narrative

Siemens filed the initial mdr 1219913-2017-00069 on 03/31/2017 for a normal advia centaur xp ft4 result compared to an above normal alternate ft4 test method result.Additional information (04/11/2017): siemens has reviewed the complaint information.The patient's advia centaur xp tsh and ft3 results are normal, and that a normal ft4 result was expected based on clinical evidence.The customer agrees that the issue appears to be with the above normal alternate test method ft4 result.The customer declines further follow up on this issue.Correction (05/04/2017): the reference in the initial mdr to fsh under other assay results was incorrect and it should have stated tsh.The instrument is performing within specifications.No further evaluation of the device is required.

• Brand Name: ADVIA CENTAUR XP FT4
• Type of Device: RADIOIMMUNOASSAY, FREE THYROXINE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS, INC; 333 coney street; east walpole, MA 02032
• Manufacturer Contact: stephen perry ; 333 coney street; east walpole, MA 02032 ; 5086604163
• MDR Report Key: 6451021
• MDR Text Key: 71588229
• Report Number: 1219913-2017-00069
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132249
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Medical Technologist
• Device Expiration Date: 10/13/2017
• Device Model Number: N/A
• Device Catalogue Number: 10282218
• Device Lot Number: 113076
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/11/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/13/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1