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

Model Number N/A

Device Problems Incorrect Or Inadequate Test Results (2456); Calibration Problem (2890)

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

Event Date 12/26/2016

Event Type  malfunction  

Manufacturer Narrative

The cause for the discordant ft4 results is unknown.The bio-rad quality control was within normal range and no instrument errors were found with the system during the event.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

False low advia centaur xp ft4 result was obtained for samples from nine patients during physical examination.The results were considered discordant with the ft3 and tsh3-ul results that were measured at the same time.The ft3 and tsh3-ul results supported euthyroid clinical condition.The results were reported to the physician and were questioned.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 1219913-2016-00263 on december 29, 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.

Manufacturer Narrative

Siemens filed the initial mdr 1219913-2016-00263 on december 29, 2016.Siemens filed the mdr 1219913-2016-00263 supplemental report 1 on january 13, 2017.On 01/19/2017 additional information: providing the information for correction/removal reporting #: 1219913-01/10/2017-002-r.

• 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: 6213411
• MDR Text Key: 63616125
• Report Number: 1219913-2016-00263
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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,Followup
• Report Date: 01/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2016
• 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: 06490092
• Device Lot Number: 113072
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2017
• 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