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

Model Number N/A

Device Problems Calibration Problem (2890); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 09/29/2016

Event Type  malfunction  

Manufacturer Narrative

The cause for the discordant ft4 results is unknown.Siemens healthcare diagnostics is investigating.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 low advia centaur xp ft4 result was obtained for samples from four patients.The results were discordant with an alternate method.The patient samples were tested on two advia cenatur xp systems and once on the alternate method.The initial results were reported to the physician.No corrected reports were issued.Patient treatment was not prescribed or altered.There was no report of adverse health consequences due to the discordant ft4 result.

Manufacturer Narrative

Siemens filed the initial mdr 1219913-2016-00184 on october 13, 2016.On 01/05/2017 additional information: siemens has performed an internal investigation and has confirmed a negative bias for the advia centaur ft4 when used with calibrator a kit lots ending in 90 on the advia centaur, advia centaur xp and advia centaur xpt systems.In addition, siemens healthcare diagnostics confirmed the potential for calibration failures due to above limit calibrator rlu %cvs when using calibrator a kit lots ending in 90 with the ft4 assay.Siemens issued ufsn cc 17-04.A.Ous (january 2017) and umdr cc 17-04.A.Us (january 2017) informing the customer of ft4 assay negative bias observed with calibrator a kit lots ending in 90.Instructions on actions to be taken are provided in the customer communication.

• 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: 6026246
• MDR Text Key: 57315730
• Report Number: 1219913-2016-00184
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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,Followup
• Report Date: 01/26/2017

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 Expiration Date: 04/04/2017
• Device Model Number: N/A
• Device Catalogue Number: 06490106
• Device Lot Number: 113072
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/29/2016
• Initial Date FDA Received: 10/13/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/26/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/03/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 1219913-01/10/2017-002-R
• Patient Sequence Number: 1