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 10/04/2016

Event Type  malfunction  

Manufacturer Narrative

The cause for the discordant ft4 results is unknown.Siemens healthcare diagnostics has requested additional information and also requested if the patient samples are available for further testing and investigation.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 high advia centaur xp ft4 result was obtained for a patient sample.The patient sample was repeated and the result was high.The ft3 and tsh3-ultra results indicated a hypothyroid condition.Repeat testing was performed on an alternate method.The result was lower which was in agreement with the clinical picture of the patient.Patient treatment was not prescribed or altered.There was no report of adverse health consequences due to the discordant ft4 result.

Manufacturer Narrative

On 10/07/2016 additional information: the customer was using calibrator lot ca89.The quality control data was provided at the time the patient sample was tested.The quality control (qc) was in range at the time of the run.Qc data: bio-rad control lot 40311 10.6 pmol/l (mean 9.48 pmol/l, range 7.14 --11.8 pmol/l); bio-rad control lot 40313 47.28 pmol/l (mean 40.9 pmol/l, range 32.5 --49.4 pmol/l).The serum samples from the patients can not be returned to the manufacturer site for testing and investigation due to (b)(6) customs.Therefore, the cause can not be determined.The cause for the discordant ft4 results is unknown.There may be some type of interferent that is present in the patient sample that is detected by the advia centaur xp ft4 assay.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: 6014799
• MDR Text Key: 57402784
• Report Number: 1219913-2016-00189
• 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: Recall
• Type of Report: Initial,Followup
• Report Date: 10/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/03/2017
• Device Model Number: N/A
• Device Catalogue Number: 06490106
• Device Lot Number: 113071
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/07/2016
• 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
• Patient Age: 61 YR