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	05/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer service engineer (cse) was sent to the customer site for system inspection.The cse performed total service call and no hardware issues were found.The cse checked the following: tubing and fitting checked for leaks.Wash station was checked and aspirate probes wash was verified.Lumonometer was cleaned and inspected.Dark counts were performed and within range.Sample and reagent probes were inspected and calibrations were verified.System fluidics were verified.The customer observed a false elevated tni-ultra result that did not match clinical picture.The sample was repeated on the same and a different instrument and it recovered below the 99th cutoff for the assay.Quality control (qc) was in range and this was the only sample affected.Service went on site and performed a full service call and found no instrument issues.This is therefore an event isolated to this particular sample.The customer uses an abbreviated spin protocol/5 minute spin.Preanalytic variables can affect the quality of the sample, and deviation from recommended best practices can lead to erroneous results.While there is insufficient information to determine the cause of the false results, preanalytic factors leading to fibrin interference as the causative agent cannot be ruled out.The cause for the discordant 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 falsely elevated advia centaur cp troponin ultra (tni-ultra) result was obtained for a patient sample.The result was reported to the physician and questioned.The patient sample was repeated and the result was negative.The patient sample was tested on the alternate system and the result was negative.A new sample was tested, and the result was negative.A corrected report was issued.Patient treatment was not 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: 8698141
• Report Number: 1219913-2019-00105
• Device Sequence Number: 14071664
• 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
• Report Date (Section B): 06/13/2019

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: 12/18/2019
• Device Model Number: N/A
• Device Catalogue Number: 10317709
• Device Lot Number: 49950151
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2019
• Initial Report FDA Received Date: 06/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1