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

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The tube type is sodium heparinized green top tube with gel.The sample tube was initially spun for 6 minutes at 3410 rpms using a swing out centrifulge (gel is flat).The customer confirmed the reagent readypack was well mixed and there was no evidence of reagent clumping in the pack.The customer alleged the sample was fine and no visible clots or fibrin strands noted.The sample was not respun prior to either repeat testing.The siemens customer service engineer (cse) was sent to the customer site for system inspection.The cse performed the total service call and no issues were identified.The cse inspected the specimen and found no issues.The customer ran quality control without any errors or discrepant results.The cause for the discordant tni-ultra result is unknown.Siemens healthcare diagnostics is investigating.The instruction for use (ifu) 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.".
Event or Problem Description
A falsely elevated advia centaur xp troponin ultra (tni-ultra) result was obtained for a patient sample.The result was reported for the in-patient and questioned by the physician.The patient sample was repeated without respinning and the result was negative.A corrected report was issued.The lead technician repeated the same sample tube in the morning, without respinning the tube, and the result was negative.The corrected result matched the patient's clinical symptoms.Patient treatment was not prescribed or altered.There was no report of adverse health consequences due to the discordant tni-ultra result.
Additional Manufacturer Narrative
Siemens filed the initial mdr 1219913-2018-00164 on june 07, 2018.06/08/2018 additional information: post service follow up with the customer confirmed no further issues noted with the quality controls or patient samples for tni-ultra.The cause for the discordant advia centaur xp tni-ultra result is unknown.Preanalytic variables can affect the quality of the sample.While there is insufficient information to determine the cause of the false results, we cannot rule out preanalytic factors as the causative agent.The instrument is performing within specifications.No further evaluation of the device is required.

• Brand Name: ADVIA CENTAUR XP TNI-ULTRA ASSAY
• Common Device Name: TROPONIN IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• MDR Report Key: 7577824
• Report Number: 1219913-2018-00164
• Device Sequence Number: 284045
• Product Code: MMI
• UDI-Device Identifier: 00630414516226
• UDI-Public: 00630414516226
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K053020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/20/2018
• Device Model Number: N/A
• Device Catalogue Number: 10317709
• Device Lot Number: 82258130
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/21/2018
• Supplement Date Received by Manufacturer: 06/08/2018
• Initial Report FDA Received Date: 06/07/2018
• Supplement Report FDA Received Date: 06/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1