MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR CP 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	04/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A siemens customer service engineer (cse) was sent to the customer site for system inspection.The cse verified the fluidics, cleaned the luminometer, and calibrated the probes.The cse cleaned and lubricated the sample syringe.The customer states that the sample integrity was good on the li++ separator tube, no apparent issues and the centrifugation speed was 85,00 rpm and the time was 3 minutes.The quality control (qc) was in range at the time the patient sample was run.No issues with other samples.The patient sample was processed using a stat spin method.While the exact root cause of the falsely elevated result cannot be determined, preanalytic factors leading to fibrin interference as the causative agent can not be ruled out.Preanalytic variables can affect the quality of the sample and deviation from recommended best practices can lead to erroneous results.The system maintenance also cannot be fully ruled out.The cse cleaned and lubricated the sample syringe.All testing done post service was acceptable.The assay works as specified.The cause for the false high tni-ultra result is unknown.The instrument is performing within specifications.No further evaluation of the device is required.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 false high advia centaur cp troponin ultra (tni-ultra) result was obtained for a patient sample.The patient sample was repeated on the other advia centaur cp and the result was negative.The patient sample was then repeated on both instruments and the results were negative.No physician questioned the result and no corrected report was issued.It is unknown if patient treatment was prescribed or altered.There was no report of adverse health consequences due to the discordant tni-ultra result.

• Brand Name: ADVIA CENTAUR CP 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: 7514329
• Report Number: 1219913-2018-00145
• Device Sequence Number: 1758654
• 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: Health Professional
• Type of Report: Initial
• Report Date (Section B): 05/15/2018

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: 67433132
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2018
• Initial Report FDA Received Date: 05/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1