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

Model Number ADVIA 1800

Device Problem Low Test Results (2458)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/18/2014

Event Type  malfunction  

Event Description

Discordant, falsely low chloride results were obtained on multiple patient samples on an advia 1800 instrument.The discordant chloride results were reported to the physician(s).The samples were repeated on an alternate system and reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant chloride results.

Manufacturer Narrative

A siemens customer service engineer (cse) was dispatched to the customer site.The cse evaluated the instrument and instrument data.After instrument evaluation, the cse determined that the equilibration chamber motor was not operational.The cse replaced the equilibration chamber, buffer pump seals and ion selective electrode tubing.The cse calibrated the ion selective electrodes and determined that the customer previously replaced the chloride electrode.The cause of the discordant chloride results was due to a equilibration chamber malfunction.The cse successfully ran quality controls.The instrument is performing according to specifications.No further evaluation of the device is required.

• Brand Name: ADVIA 1800
• Type of Device: CHEMISTRY ANALYZER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): JEOL LTD, 3-1-2 MUSASHINO AKISHIMA; registration number:3003637681; tokyo, 196- 8558; JA 196-8558
• Manufacturer Contact: john nelson ; 511 benedict avenue; tarrytown, NY 10591 ; 9145242530
• MDR Report Key: 3930458
• MDR Text Key: 4583625
• Report Number: 2432235-2014-00416
• Device Sequence Number: 1
• Product Code: CGZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K990346
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/18/2014

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
• Device Operator: Health Professional
• Device Model Number: ADVIA 1800
• Device Catalogue Number: 073-A021-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/18/2014
• Initial Date FDA Received: 07/11/2014
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1