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

Model Number	N/A
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
While there is insufficient information available to identify the root cause of the non-reproducible elevated result, preanalytic factors leading to fibrin interference cannot be ruled out.This issue was isolated to this one sample.Qc was in range at the time the sample was run and no other samples indicated an issue.Preanalytic variables can affect the quality of the sample.The summary and explanation of the test section of the instruction for use (ifu) 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
Customer observed an elevated advia centaur cp troponin ultra - (tni-ultra) result that was lower upon repeat testing.There are no reports that treatment was altered or prescribed or adverse health consequences due to the elevated advia centaur cp 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: 8367826
• Report Number: 1219913-2019-00022
• Device Sequence Number: 1995021
• 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): 02/25/2019

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: 05/09/2019
• Device Model Number: N/A
• Device Catalogue Number: 10317709
• Device Lot Number: 97103141
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2019
• Initial Report FDA Received Date: 02/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1