MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR TROPONIN ULTRA (TNI-ULTRA) ASSAY; TROPONIN IMMUNOASSAY

Model Number N/A

Device Problem Imprecision (1307)

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

Event Date 10/13/2014

Event Type  malfunction  

Event Description

Imprecise advia centaur troponin ultra (tni-ultra) results were obtained on twenty five patient samples during a method evaluation of reagent lot # 010086.No results were reported to physicians.Patient treatment was not prescribed or altered.There was no report of adverse health consequences due to the discordant troponin ultra results.

Manufacturer Narrative

The cause for the discordant troponin ultra results is unknown.A siemens customer service engineer (cse) was sent to the customer site for system inspection.Inspection in process.The instruction for use under the summary and explanation of the test section states the following: "always analyze ctni results in the context of time elapsed since patient presentation to the hospital.Serial sampling is recommended to detect the temporal rise and fall of troponin levels characteristic of mi.In accord with published recommendations, serial testing of ctni at intervals of 2 to 4 hours for up to 12 to 24 hours is suggested to corroborate a single ctni result.An elevated troponin alone is not sufficient to make the diagnosis of mi.Other markers, such as ck-mb and myoglobin, can be used in conjunction with ctni results in aiding the diagnosis of mi.".

Manufacturer Narrative

Siemens filed the initial mdr 1219913-2014-00265 on october 24, 2014.On 01/06/2015 additional information: a customer service engineer (cse ) was sent to the customer site for system inspection.The cse replaced the valve manifold in dispense port 3 on the advia centaur sn: (b)(4).The imprecision with reagent lot 010086 was resolved.The customer was provided with troponin ultra reagent lot # 010087 for troubleshooting.There were no precision issues observed with reagent lot 010087.The reagent lot 010087 met the customer's expectations.The instrument is performing according to specifications.No further evaluation of the device is required.

• Brand Name: ADVIA CENTAUR TROPONIN ULTRA (TNI-ULTRA) ASSAY
• Type of Device: TROPONIN IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 333 coney street; e. walpole MA 02032
• Manufacturer Contact: eiman sulieman ; 333 coney street; e. walpole, MA 02032 ; 5086604603
• MDR Report Key: 4199824
• MDR Text Key: 5152495
• Report Number: 1219913-2014-00265
• Device Sequence Number: 1
• Product Code: MMI
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K053020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 10/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/02/2015
• Device Model Number: N/A
• Device Catalogue Number: 02790309
• Device Lot Number: 010086
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/06/2015
• Was Device Evaluated by Manufacturer?: No
• 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