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 10/19/2016

Event Type  malfunction  

Manufacturer Narrative

The cause for the discordant ft4 results between two reagent readypacks is unknown.The calibration and quality control (qc) were run on the first reagent readypack.The calibration and qc were valid at the time the samples were run.The calibrator used was lot ca89.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 three patients during physical examination.The patient samples were repeated with a freshly opened reagent readypack from the same lot.The results were higher.The repeat results were reported to the physician.The repeat results were in agreement with the clinical picture of the patients.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 1219913-2016-00202 on october 31, 2016.On 11/08/2016 additional information: the suspected readypack could not be returned to the manufacturer site for further testing due to china customs issues.Therefore, the cause could not be determined.The cause for the discordant ft4 results between two reagent readypacks is unknown.The instrument is performing within specifications.No further evaluation of the device is required.

• 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: 6067765
• MDR Text Key: 58817032
• Report Number: 1219913-2016-00202
• 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
• Report Date: 11/09/2016

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: 10/27/2016
• Initial Date FDA Received: 10/31/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/09/2016
• 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
• Patient Sequence Number: 1