MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR CP 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 discordant advia centaur cp ft4 results is unknown.Siemens healthcare diagnostics has requested that remaining readypacks from lot 073 be sent to siemens for additional testing.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 elevated advia centaur cp ft4 results that did not match the clinical picture or the results from another lot of reagents for two patient samples.There are no reports that treatment was altered or prescribed or adverse health consequences due to the elevated advia centaur cp ft4 results.

Manufacturer Narrative

Siemens filed mdr 1219913-2016-00218 on november 18, 2016 reporting advia centaur cp ft4 results that did not match the clinical picture or the results from another lot of reagents for two pt samples.On (b)(6) 2016 simens performed a study with bio-rad controls of lot 40310 and pt samples with advia centaur cp ft14 reagent lot 073 and calibrator a lot 90.Results: 40311 - 0.880 ng/ml, 40312 - 2.31 ng/ml, 40313 - 3.69 ng/ml.Controls are in range: 40 samples were tested with advia centaur ft4 reagent lots 073 and 074 and calibrator a lot 90.The mean bias between the two reagent lots was 3.4% and median bias was 3.3% and the normal range was verified.The customer will send in unused ready packs of reagent lot 073 for siemens to further investigate.

Manufacturer Narrative

Mdr 1219913-2016-00218 was filed on november 18, 2016 reporting elevated advia centaur cp ft4 results that did not match the clinical picture or the results from another lot of reagents for two patient samples.Mdr 1219913-2016-00218 supplemental 1 was filed on december 19, 2016 with initial results of siemens investigation.January 18, 2017 - additional information and evaluation results customer reported that they are using advia centaur cp ft4 reagent lot 75 and calibrator a lot 90 and all qc levels are in range and close to the mean.Ft4 qc data: lot#075/ca90; l1=0.81 (b)(6) 2017; cust range=0.61-1.01; l2=2.27 (b)(6) 2017; cust range=1.76-2.76; l3=3.59 (b)(6) 2017; cust range=2.94-4.60.Siemens received two additional readypacks of advia centaur ft4 lot 073 from the customer and tested them side by side with one internal readypack of lot 073 and one readypack of lot 074 with qc and patient samples.The percent difference to target of the qc results are below.In-house readypacks customer returned readypacks lot 073 : lot 074: lot 073 #1: lot 073 #2: (b)(6) 3.7; -2.5; 27.0; 21.8.(b)(6) -0.4; -4.0; 16.2; 16.9.(b)(6) -0.1; -5.8; 14.0; 12.9.The percent difference to target results shows a marked increase compared to the in-house readypacks for the patient samples the percent differences to the lot 073 in-house readypack results were calculated for the other three readypacks.Results are below.074 in-house customer 073 #1 customer 073 #2 (b)(6).Results from controls and patient samples confirm the customers observation of high results on the customer returned lot 073 readypacks only.The in-house lot 073 readypack tested did not show the same high results.A possible root cause could be improper shipping of the readypacks.

• 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: 6113204
• MDR Text Key: 60435333
• Report Number: 1219913-2016-00218
• 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: Health Professional
• Remedial Action: Inspection
• Type of Report: Initial,Followup,Followup
• Report Date: 02/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2016
• 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: 46879073
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1