MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA CENTAUR XP

Model Number	ADVIA CENTAUR XP
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted a siemens customer care center (ccc).A siemens customer service engineer (cse) was dispatched to the customer's site.Cse inspected the instrument and advised the customer to use the arrowhead deionized (di) water bottle until the main deionized (di) source is fixed.The initial result was obtained while the qc was out of range and the repeat testing results were produced after calibration with a new reagent pack.Calibration and qc was run.The system was functioning properly based upon completion of the specific service task undertaken by siemens and will continue to further investigate the issue for probable cause.
Event or Problem Description
Discordant, falsely high cancer antigens br (ca27.29) patient result was obtained on an advia centaur xp instrument.The initial result was not reported to the physician(s).Repeat sample was repeated three times on the same instrument, all resulting in a lower value.The repeat results were considered the correct results and was reported to the physician(s).There are no reports of patient intervention or adverse health consequences due to the discordant results.
Additional Manufacturer Narrative
Siemens filed the initial mdr 2432235-2019-00360 on 04-oct-2019.Additional information (04-dec-2019): the customer contacted a siemens customer care center (ccc).A siemens customer service engineer (cse) was dispatched to the customer's site.Cse inspected the instrument and advised the customer to use the arrowhead deionized (di) water bottle until the main deionized (di) source is fixed.Calibration and qc was run.Cse checked for bleach contamination in the reagent probes and wash manifold and noticed that there was bleach in the wash ports and the acid and base lines.Cse replaced valve 66 and 67 and denominated the wash manifold.Cse ran calibrators, precision tests, and quality controls (qc) and all passed successfully.Siemens concluded that the cause was due to the bleach valve malfunction leading to the contamination.The instrument is performing according to specifications.No further evaluation of this device is required.

• Brand Name: ADVIA CENTAUR XP
• Common Device Name: ADVIA CENTAUR XP
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• MDR Report Key: 9158127
• Report Number: 2432235-2019-00360
• Device Sequence Number: 2113291
• Product Code: JJE
• UDI-Device Identifier: 00630414196657
• UDI-Public: 00630414196657
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K971418
• 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): 12/16/2019

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
• Device Catalogue Number: 10364455
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/10/2019
• Supplement Date Received by Manufacturer: 12/04/2019
• Initial Report FDA Received Date: 10/04/2019
• Supplement Report FDA Received Date: 12/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1