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 03/06/2017

Event Type  malfunction  

Manufacturer Narrative

The cause for the discordant ft4 results is the presence of anti-t4 antibody.This was confirmed by the customer.The customer sent the sample to a reference laboratory where the sample was run for the measurement of anti-t4 using a radioisotope method.It seems to be a qualitative method where it is considered a positive result when the percentage of fixation is above 10.For this patient sample, the percentage of fixation was 30%.The patient sample is not available for further testing.The instrument is performing within specifications.No further evaluation of the device is required.The ifu states in the interpretation of results section: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings.".

Event Description

A false high advia centaur xp ft4 result was obtained for a patient sample that did not match the tsh results.The patient sample was sent to a reference laboratory and tested with an alternate method.The result was lower.Patient treatment was not prescribed or altered.There was no report of adverse health consequences due to the discordant ft4 result.

• 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; e. walpole MA 02032
• Manufacturer Contact: eiman sulieman ; 333 coney street; e. walpole, MA 02032 ; 5086604603
• MDR Report Key: 6429552
• MDR Text Key: 70757235
• Report Number: 1219913-2017-00064
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K132249
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 03/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/25/2017
• Device Model Number: N/A
• Device Catalogue Number: 10282219
• Device Lot Number: 44710073
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/06/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/25/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1