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 11/28/2016

Event Type  malfunction  

Manufacturer Narrative

The cause of the non-reproducible advia centaur xp ft4 result is unknown.Siemens visited the customer and verified the performance of the instrument.There were no errors in the error log at the time of the even.All calibrations and qc was acceptable.The sample was tested an additional 20 times and all results were between 0.78 and 0.80 ng/dl.Siemens has requested the sample for additional testing.The instructions for use 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

Customer observed a low advia centaur xp ft4 result that did not reproduce with repeat testing.There are no reports that treatment was altered or prescribed or adverse health consequences due to the low advia centaur xp ft4 result.

Manufacturer Narrative

Mdr 1219913-2016-00251 was filed on december 28, 2016 reporting a low advia centaur xp ft4 result that did no reproduce with repeat testing.February 7, 2017 - additional information: siemens received the sample from the customer and tested it in replicates of three on reagent lot 073.The results were: replicate #1 0.80 ng/dl, replicate #2 0.87 ng/dl, replicate #3 0.83 ng/dl, mean 0.83 ng/dl.These results are similar to the customer repeat results.The most likely cause of the initial low advia centaur xp ft4 result is sample preparation or handling.

• Brand Name: ADVIA CENTAUR XP FT4
• Type of Device: RADIOIMMUNOASSAY, FREE THYROXINE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS, INC; 333 coney street; east walpole MA 02032
• Manufacturer Contact: louise mclaughlin ; 333 coney street; east walpole, MA 02032 ; 5086604381
• MDR Report Key: 6208574
• MDR Text Key: 63383650
• Report Number: 1219913-2016-00251
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K132249
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Reporter Occupation: Health Professional
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 02/21/2017

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: 05/25/2017
• Device Model Number: N/A
• Device Catalogue Number: 10282218
• Device Lot Number: 073
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/05/2016
• Initial Date FDA Received: 12/28/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/21/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/25/2016
• 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: 35 YR