MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR CP FT4; RADIOIMMUNOASSAY, FREE THYROXINE

Model Number N/A

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/01/2016

Event Type  malfunction  

Manufacturer Narrative

The cause for the discordant ft4 results is unknown.Siemens healthcare diagnostics is investigating.The interpretation of results section of the instructions for use states: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings.".

Event Description

Customer observed an elevated result on a patient sample for advia centaur cp ft4 when moving from reagent lot 066 to reagent lot 074.There are no reports that treatment was altered or prescribed or adverse health consequences due to the elevated advia centaur cp ft4 result.

Manufacturer Narrative

Mdr 1219913-2016-00249 was filed on (b)(4) 2016 reporting that a customer observed an elevated result on a patient sample for advia centaur cp ft4 when moving from reagent lot 066 to reagent lot 074.On december 28, 2016 - additional information: siemens service went on site and replaced a leaking wash block and resolved the issue.No further investigation is required.

• Brand Name: ADVIA CENTAUR CP 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: 6197827
• MDR Text Key: 63062579
• Report Number: 1219913-2016-00249
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132249
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Medical Technologist
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 01/12/2017

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: Medical Technologist
• Device Expiration Date: 07/11/2017
• Device Model Number: N/A
• Device Catalogue Number: 10282220
• Device Lot Number: 69622074
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/01/2016
• Initial Date FDA Received: 12/22/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/12/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/11/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1