MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XP CYCLOSPORINE (CSA) ASSAY; CYCLOSPORINE ASSAY

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	01/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cause for the discordant advia centaur xp cyclosporine (csa) results is unknown.Siemens reviewed the customer data.The overall bias is in line with what is expected in the advia centaur cyclosporine ifu (instructions for use), 10629836_en rev, k, 2017-12 accuracy/method comparison section with tandem-ms.In addition the advia centaur cyclosporine assay does not have a claim to be comparable to any other methods or platforms.The lc/ms/ms methods also do not seem to be in alignment with each other and demonstrate variability.The instrument is performing within specifications.No further evaluation of the device is required.The ifu states in the interpretation of results: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings." the ifu states in the limitations section: "always use measurements of csa in conjunction with other diagnostic procedures, including information from the patient's clinical evaluation.".
Event or Problem Description
A high advia centaur xp cyclosporine (csa) result was obtained on a patient sample during a method comparison.The cyclosporine results were higher than the lc-ms/ms methods.The patient sample was tested on the lc-ms/ms at two laboratories.The initial results were reported and questioned by one physician.Corrected results were reported.Patient treatment was not prescribed or altered.There was no report of adverse health consequences due to the discordant cyclosporine (csa) results.

• Brand Name: ADVIA CENTAUR XP CYCLOSPORINE (CSA) ASSAY
• Common Device Name: CYCLOSPORINE ASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• MDR Report Key: 7436765
• Report Number: 1219913-2018-00130
• Device Sequence Number: 19106137
• Product Code: MKW
• UDI-Device Identifier: 00630414524450
• UDI-Public: 00630414524450
• Combination Product (Y/N): N
• PMA/510(K) Number: K071455
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/17/2018

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: 05/01/2019
• Device Model Number: N/A
• Device Catalogue Number: 10335448
• Device Lot Number: 77934031
• 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: 03/27/2018
• Initial Report FDA Received Date: 04/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1