MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA CENTAUR XP; CLINICAL CHEMISTRY ANALYZER

Model Number	ADVIA CENTAUR XP
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted the siemens customer care center (ccc).A siemens customer service engineer (cse) was dispatched to the customer site.The cse inspected the user interface (ui) module and com port, and no physical damage was observed.The ui was cleaned and all connections at the ui module were reset.The cable from the instrument to the host computer was inspected and the pin configuration was verified.The cable from the instrument to the host computer was replaced proactively and the host application was reinstalled.The siemens regional support center (rsc) and headquarter support center (hsc) are investigating this issue.
Event or Problem Description
The customer informed siemens of two patient sample results that were transferred to the laboratory information system (lis) host computer and displayed incorrect results.The initial results obtained on the advia centaur xp instrument were transferred to the lis and the results, displayed on the host computer, were different and some included non-numerical values.The patient results were not reported to the physician(s).Repeat testing was not performed to confirm correct results.There are no known reports of patient intervention or adverse health consequences due to the discordant patient results.
Additional Manufacturer Narrative
Siemens filed the initial mdr 2432235-2018-00213 on 18-may-2018.Additional information (12-july-2018): a siemens headquarter support center (hsc) specialist evaluated the service performed by the siemens customer service engineer (cse).The hsc specialist determined there was no recurrence of the issue.The instrument is performing within specifications.No further evaluation of the device is required.Section h6 (results code and conclusions code) were updated.

• Brand Name: ADVIA CENTAUR XP
• Common Device Name: CLINICAL CHEMISTRY ANALYZER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• MDR Report Key: 7527559
• Report Number: 2432235-2018-00213
• Device Sequence Number: 1254312
• Product Code: JJE
• UDI-Device Identifier: 00630414585475
• UDI-Public: 00630414585475
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K971418
• 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): 08/07/2018

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 Model Number: ADVIA CENTAUR XP
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/24/2018
• Supplement Date Received by Manufacturer: 07/12/2018
• Initial Report FDA Received Date: 05/18/2018
• Supplement Report FDA Received Date: 08/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1