MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA 1800 ANALYZER; ADVIA CHEMISTRY

Model Number	ADVIA 1800
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A siemens customer service engineer (cse) was dispatched to the customer site.The cse decontaminated the instrument and rebuilt the pumps.The cse found the reaction tray wash unit drain valve 1 (cdev1) on the reaction tray wash unit (wud) not opening and replaced the valve; cleaned and checked filtration of mix 1 wash port, checked wud aspirators, replaced the large water pump (lwp) filter, and adjusted the alignment of the reagent pipetting probe 1 (rpp1) wash port.The cse cleaned and verified full drain of rpp1 wash port, installed the external degasser and ran qc as well as multiple samples.All passed and no outliers were seen.The cause of the discordant, falsely elevated carbon dioxide concentrated (co2_c) on the two patient samples is unknown.No further issues with co2_c after service was dispatched.The device is performing within manufacturing specifications.No further evaluation of the device is required.
Event or Problem Description
Discordant, falsely elevated carbon dioxide concentrated (co2_c) results were obtained on 2 samples on an advia 1800 instrument.The discordant results were not reported to the physician(s).The samples were repeated on the same instrument and they resulted lower.The corrected results were reported to the physician(s).There are no reports of patient intervention or adverse health consequences due to the discordant, falsely elevated carbon dioxide concentrated results.

• Brand Name: ADVIA 1800 ANALYZER
• Common Device Name: ADVIA CHEMISTRY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• MDR Report Key: 7293808
• Report Number: 2432235-2018-00087
• Device Sequence Number: 1342876
• Product Code: JJE
• UDI-Device Identifier: 00630414553177
• UDI-Public: 00630414553177
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K990346
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 02/23/2018

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 1800
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/03/2018
• Initial Report FDA Received Date: 02/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1