MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ATELLICA IM TROPONIN I ULTRA (TNI-ULTRA); TROPONIN I IMMUNOASAY

Model Number	10995696
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cause for the discordant atellica im tni-ultra result is unknown.Siemens healthcare diagnostics is investigating.The interpretation of results of the instructions for use states, "results of this assay should always be interpreted in conjunction with the patient's medical history, clinical presentation, and other findings.".
Event or Problem Description
A customer obtained one discordant (elevated) result on one patient sample draw (draw #2) with atellica im troponin i ultra (tni-ultra) compared to repeat result from the same sample and the results of different sample draws from the same patient and versus an alternate method.No issues were observed with any other patients regarding atellica im tnl-ultra.The customer believes that the discordant result was due to the specific sample.Patient treatment was not prescribed, altered or delayed.There was no report of adverse health consequences due to the discordant high tni-ultra result.
Additional Manufacturer Narrative
Siemens healthcare diagnostics filed initial mdr 1219913-2020-00035 on 02/06/2020.Additional information 02/11/2020: the instrument log files requested by siemens were sent via siemens secure file exchange.Additional information 2/19/2020: the customer reported a discordant elevated tniu result on one patient.The sample was later repeated on an alternate atellica analyzer and was low/negative.Siemens reviewed the available information to determine probable root cause.Quality control was in range at the time of the incident and no other patient sample results were affected.Siemens reviewed the instrument hardware log files (icdebug and sample/reagent integrity logs) and was not able to find any hardware issues that may have caused the falsely elevated result.The sample was collected in lithium heparin plasma tube and processed for approximately 5000 rpm for 5 minutes.A sample integrity error was generated by the system when the sample was repeated.Preanalytic variables can affect the quality of the sample and can lead to erroneous results.While there is insufficient information to determine the cause of the false results, siemens cannot rule out preanalytic factors leading to fibrin interference as the causative agent.No product performance issue confirmed.The customer is operational.Based on the investigation, no product problem was identified.No further evaluation of the device is required.

• Brand Name: ATELLICA IM TROPONIN I ULTRA (TNI-ULTRA)
• Common Device Name: TROPONIN I IMMUNOASAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• MDR Report Key: 9678562
• Report Number: 1219913-2020-00035
• Device Sequence Number: 2371380
• Product Code: MMI
• UDI-Device Identifier: 00630414600093
• UDI-Public: 00630414600093
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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,Followup
• Report Date (Section B): 03/02/2020

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: 06/16/2020
• Device Model Number: 10995696
• Device Catalogue Number: N/A
• Device Lot Number: 47877167
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/16/2020
• Supplement Date Received by Manufacturer: 02/11/2020
• Initial Report FDA Received Date: 02/06/2020
• Supplement Report FDA Received Date: 03/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 41 YR