MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENATUR 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

The cause for the false high advia centaur xp ft4 results on two patient samples compared to lower repeat ft4 results is unknown.The customer's quality control results were within normal range, and there were no instrument errors observed at the time of the event.Siemens is investigating the incident.The instruction for use (ifu) under the interpretation of results section states the following: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings.".

Event Description

False high advia centaur xp ft4 results were obtained by the customer on two patient samples.The elevated ft4 results were considered discordant when compared to lower repeat ft4 results, and other thyroid test results that supported euthyroid.The lower ft4 results were reported to the physician(s).Patient treatment was not prescribed or altered.There was no report of adverse health consequences due to the discordant ft4 results.

Manufacturer Narrative

Siemens filed the initial mdr 1219913-2016-00217 on 11/21/2016 for false high advia centaur xp ft4 results on two patient samples.On 11/29/2016 - additional information: the cause for the non reproduced elevated ft4 results compared to lower ft4 repeat results, and other thyroid test results that supported euthyroid is unknown.The patient samples are not available for further investigation.No conclusion can be drawn.On 12/07/2016 - initial reporter: country is (b)(6) and not us as initially reported.The instruction for use (ifu) under the interpretation of results section states the following: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings." the instrument is performing within specification.No further investigation is required.

• Brand Name: ADVIA CENATUR 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: 6117711
• MDR Text Key: 60638942
• Report Number: 1219913-2016-00217
• 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
• Type of Report: Initial,Followup
• Report Date: 12/07/2016

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: No Information
• Device Expiration Date: 04/04/2017
• Device Model Number: N/A
• 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: 11/10/2016
• Initial Date FDA Received: 11/21/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/07/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/29/2016
• 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