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

Model Number ADVIA CENTAUR XP

Device Problems Mechanical Problem (1384); Nonstandard Device (1420); Calibration Problem (2890)

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

Event Date 11/02/2016

Event Type  malfunction  

Manufacturer Narrative

A siemens customer service engineer (cse) was dispatched to the customer's site.The cse performed an acid and base decontamination and check the relative light units, resulting in range.The cse ran calibration, resulting in range.The cse ran quality control (qc) which resulting out of range.The cse ran a four day precision study and two patient samples, resulting within range.Qc resulted within range and one precision result was out of range.The cse replaced the reagent probe 1 diluter syringe.The customer moved the instrument and qc shifted in range and matches the alternate advia centaur instrument.The cause of the discordant, falsely depressed free thyroxine (ft4) results is unknown.The instrument is performing according to specifications.No further evaluation of the device is required.

Event Description

Discordant, falsely depressed free thyroxine (ft4) results were obtained on two patient samples on an advia centaur xp instrument.The initial results were sent out to the physician(s), which were not questioned.The same samples were repeated on an alternate advia centaur instrument, resulting higher.Corrected reports were issued to the physician(s).There are no reports of patient intervention or adverse health consequences due to the discordant, falsely depressed free thyroxine results being reported out.

Manufacturer Narrative

The initial mdr 2432235-2016-00802 was filed on december 22, 2017.Additional information (01/05/2017): 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.; registration #: 1219913; 333 coney st. e; walpole MA 02032
• Manufacturer Contact: timothy rice ; 511 benedict ave; tarrytown, NY 10591 ; 9145242406
• MDR Report Key: 6200623
• MDR Text Key: 63207132
• Report Number: 2432235-2016-00802
• Device Sequence Number: 0
• Product Code: CEC
• Reporter Country Code: US
• PMA/PMN Number: K971418
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 01/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ADVIA CENTAUR XP
• Device Catalogue Number: 10282218
• Device Lot Number: 113072
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/02/2016
• Initial Date FDA Received: 12/22/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/31/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/21/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: 1219913-01/10/2017-002-R
• Patient Sequence Number: 1