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	09/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A siemens customer service engineer (cse) was sent to the customer's site for system inspection.The cse performed a total service call, and found no system related issues.The luminometer was inspected and cleaned.The wash station was inspected, and the port dispenses/aspirations were checked.The probes, syringes, pumps, tubing, and fittings were checked.Precision checks by the cse after this incident was acceptable.The customer's quality control was in range at the time of the incident, and the issue is considered to be sample specific.Pre-analytic variables can affect the quality of the sample, and deviation from recommended best practices (abbreviated centrifuge spin time) can lead to erroneous results.While there is insufficient information to determine the cause of the non-reproduced elevated tni-ultra result, pre-analytic factors leading to fibrin interference as the causative agent cannot be ruled out.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 instrument is performing within specification.No further evaluation of the device is required.
Event or Problem Description
A falsely elevated advia centaur cp cardiac troponin i (tni-ultra) result was observed on the evening shift by laboratory supervisor when reviewing troponin patient results.The second drawn tni-ultra result for this patient was normal.The customer performed repeat tni-ultra testing on an alternate advia centaur cp system of the first sample, and the results were normal.A corrected report was issued.There are no reports of 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: 7949625
• Report Number: 1219913-2018-00245
• Device Sequence Number: 19417593
• Product Code: MMI
• UDI-Device Identifier: 00630414516226
• UDI-Public: 00630414516226
• Combination Product (Y/N): N
• 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
• Type of Report: Initial
• Report Date (Section B): 10/09/2018

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: 02/17/2018
• Device Model Number: N/A
• Device Catalogue Number: 10317708
• Device Lot Number: 010137
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2018
• Initial Report FDA Received Date: 10/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1