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 11/01/2016

Event Type  malfunction  

Manufacturer Narrative

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 (b)(4) us (january 2017) and (b)(4) (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.No further investigation is required.

Event Description

Low advia centaur xp ft4 patient results were obtained by the customer with calibrator cal a lot 90, and ft4 reagent lot (113071) and the results were questioned by the physician(s).The ft4 patient results were considered discordant compared to the clinical picture, and other thyroid assay results that supported euthyroid.There are no reports that treatment was prescribed or altered.There are no reports of adverse health consequences due to the discordant advia centaur xp ft4 results.

• 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: 6340015
• MDR Text Key: 67927147
• Report Number: 1219913-2017-00039
• 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: Health Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 02/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 03/03/2017
• Device Model Number: N/A
• Device Catalogue Number: 10282218
• Device Lot Number: 113071
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/02/2016
• 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