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 01/30/2017

Event Type  malfunction  

Manufacturer Narrative

The cause for the false high advia centaur xp ft4 result compared to a lower alternate ft4 test method, and the patient's previous history is unknown.Siemens is investigating.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." additional reagent lot information: lot no.32418072, expiry date 04/04/2017, udi # (b)(4), date of manufacture: 04/04/2016; 77782065, 10/29/2016, (b)(4), 10/29/2015.

Event Description

A false high advia centaur xp ft4 result was obtained by the customer on a patient sample, and considered discordant compared to the patient's ft4 test history, and other thyroid test results.The result was questioned by the physician.The patient has been monitored yearly since 2011, and the thyroid results have been in the normal ranges.There was an elevated ft4 result in (b)(6) 2016 that were considered to be unbelievable.Both samples were sent to an alternate laboratory and the ft4 results were normal.Patient treatment was not prescribed or altered.There was no report of adverse health consequences due to the discordant advia centaur xp ft4 results.

Manufacturer Narrative

Siemens filed the initial mdr 1219913-2017-00047 on 03/07/2017 for a false high advia centaur xp ft4 result on a patient sample.On 03/28/17 - additional information: patient's historical thyroid results.(b)(6): tsh3-ul 1.04 uiu.Ml, ft3 6.3 pmol/l, ft4 53.6 pmol/l.Alternate test method results: trab 0.9 iu/l, tsh 1.43, ft4 0.97 ng/dl.Patient preexisting medical information: symptoms: hypothyroid, tired and sleepy (9 hours per day).Medications: euthyrox 62.5 ug.Note: this dose was recently increased with good results.No other medications, supplements, or biotin.The patient lives on a farm with cats, dogs, rabbits, cows, and chickens.Siemens continues to investigate.

Manufacturer Narrative

Siemens filed the initial mdr 1219913-2017-00047 on 03/07/2017 for a false high free thyroxine (ft4) advia centaur xp result, and mdr 12113-2017-00047 supplemental report 1 on 04/04/2017 for additional information.On 04/20/2017 - additional information: the patient sample was returned to siemens for further testing.The sample was tested neat (undiluted), and diluted for ft4 on an advia centaur xp system, and neat on a immulite 2000 xpi system.Based on the ft4 advia centaur xp test results, an interferent could not be diluted out suggesting it is not a heterophilic or human anti-mouse antibody (hama) interferent present.The cause for the false high advia centaur xp ft4 patient result is unknown.Advia centaur xp results (ng/ml): ft4 neat: 4.46, diluted (1:20): 6.8, diluted (1:50): 9.0.Other assay results: tsh3-ultra 1.02 uiu/ml.Immulite 2000 xpi result (ng/ml): ft4 neat: 4.25 ng/ml.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 specifications.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: 6383582
• MDR Text Key: 69291747
• Report Number: 1219913-2017-00047
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: PL
• 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,Followup
• Report Date: 04/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2017
• Device Model Number: N/A
• Device Catalogue Number: 10282219
• Device Lot Number: 81102075
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/20/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/01/2016
• 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: 17 YR