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	06/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 cause for the discordant tni-ultra result is unknown.The repeat testing of the initial sample and the new sample for same patient were negative.The quality control run on the day of the issue was acceptable showing that this is isolated to the sample.No further issues with falsely elevated samples have been observed since this incident.Preanalytic variables can affect the quality of the sample.While there is insufficient information to determine the cause of the false results, preanalytic factors leading to fibrin interference as the causative agent can not be ruled out.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 xp troponin ultra (tni-ultra) result was obtained for a patient sample.The patient sample was repeated on a second advia centaur xp and the result was negative.A second sample for the same patient was tested on both advia centaur xp systems and the results were 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.
Additional Manufacturer Narrative
Siemens filed the initial mdr 1219913-2018-00184 on (b)(6) 2018.(b)(6) 2018 correction: of the initial report, the value for the sid (b)(6) initial result on the advia centaur xp #2 was incorrect.The correct value is 0.008.Of the initial report, for sid (b)(6): the decimal point was missing for the tsh result.The correct value is 0.442 mu/l the ft4 result did not belong to this sid and was removed.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: 7671576
• Report Number: 1219913-2018-00184
• Device Sequence Number: 16789392
• Product Code: MMI
• UDI-Device Identifier: 00630414516219
• UDI-Public: 00630414516219
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K053020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2018

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: 10317708
• Device Lot Number: 130
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/21/2018
• Supplement Date Received by Manufacturer: 07/25/2018
• Initial Report FDA Received Date: 07/09/2018
• Supplement Report FDA Received Date: 08/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 82 YR