MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR CP 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	05/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The patient sample was drawn into a bd serum separator primary tube, stat spun for 3 minutes and poured off into a secondary transfer tube.The reagents are homogenous.No related errors on the event log.Maintenance is up to date.No other tests with issues.No known shipping or storage issues.Other than the stat spin, all operators handle and store materials according to manufacturer's recommendations.The siemens field service engineer (fse) was sent to the customer site for system inspection.The fse performed a total service call.The fse replaced the acid rotary pump, the luminometer, acid rotary pump, wash 1 rotary pump, gray peri-pump, aspirate probe tubings, and the pcb usb converter.The reagent and sample probe have been calibrated.Uni-load and firmware upgrade were completed.The fse performed a system decontamination and ring cuvette calibration adjustments.The customer has calibrated and ran quality control (qc) on all other assays on the system.Qc is good.Tni-ultra patient pool precision run was good.The cause for the discordant tni-ultra result is unknown.Multiple parts were replaced and probe alignments were performed.The cause could not be determined.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." mdr 1219913-2018-00165 was filed for the same event.
Event or Problem Description
A false high advia centaur cp troponin ultra (tni-ultra) result was obtained for a patient sample.The result was not reported to the physician.The patient sample was repeated on the same instrument and the other advia centaur cp.The results were lower.The lower results were reported to the physician.Patient treatment was not prescribed or altered.There was no report of adverse health consequences due to the discordant 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: 7577840
• Report Number: 1219913-2018-00166
• Device Sequence Number: 19213457
• 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: Medical Technologist
• Type of Report: Initial
• Report Date (Section B): 06/07/2018

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: 69853130
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2018
• Initial Report FDA Received Date: 06/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1