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	05/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The falsely low advia centaur xp cardiac troponin i (tni-ultra) comparison results observed by the customer with reagent lot 010132 is being investigated by siemens.The summary and explanation of the test section of the instructions for use 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." the interpretation or results section of the instruction for use states the following: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings.".
Event or Problem Description
The customer observed falsely low advia centaur xp cardiac troponin i (tni-ultra) patient results when performing a comparison of reagent lot (010128) to a newer reagent lot (010132) received.There are no reports that treatment was altered or prescribed or adverse health consequences due to the low advia centaur xp tni-ultra results.
Additional Manufacturer Narrative
Siemens filed mdr on 06/08/2018 for false low advia centaur xp cardiac troponin i (tni-ultra) patient results when performing a comparison of reagent lot: (010128) to a newer reagent lot: (010132) received.07/16/2018: additional information: siemens reviewed patient samples run at quality control (qc) release for lot: 010132, and the results met specifications.Patient samples were run on advia centaur xp tni-ultra reagent lots: 010127 - 010132, and the 99th% reference range was verified.The lower patient results observed can be attributed to reagent lot to reagent lot variability.The instrument is performing within specification.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: 7582314
• Report Number: 1219913-2018-00172
• Device Sequence Number: 19490424
• Product Code: MMI
• UDI-Device Identifier: 00630414516226
• UDI-Public: 00630414516226
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2018

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: 010132
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/23/2018
• Supplement Date Received by Manufacturer: 07/16/2018
• Initial Report FDA Received Date: 06/08/2018
• Supplement Report FDA Received Date: 08/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1