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

Model Number ADVIA 1800

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/12/2014

Event Type  malfunction  

Event Description

Discordant chloride (cl) results were obtained on patient samples on an advia 1800 instrument.The discordant results were not reported to the physician(s).The samples were repeated on the same instrument, resulting higher for some and lower for others.It is unknown if the corrected results were reported to the physician(s).There are no reports of patient intervention or adverse health consequences due to the discordant cl results.

Manufacturer Narrative

A siemens customer service engineer (cse) was dispatched to the customer site.After evaluation of the instrument and instrument data, the cse replaced the mixer motor, stirrer, and seals.The cse cleaned the ion selective electrode module of salt, flushed the drain line, and calibrated the instrument.Quality controls were run, resulting within range.The cause of discordant cl results is unknown.The instrument is performing according to specifications.No further evaluation of the device is required.

• Brand Name: ADVIA 1800
• Type of Device: CLINICAL CHEMISTRY ANALYZER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): JEOL LTD; registration number:3003637681; 3-1-2 musashino akishima; tokyo, 196- 8558; JA 196-8558
• Manufacturer Contact: cassandra kocsis ; 511 benedict avenue; tarrytown 10591 ; 9145242687
• MDR Report Key: 4065519
• MDR Text Key: 4857038
• Report Number: 2432235-2014-00535
• 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: Health Professional
• Type of Report: Initial
• Report Date: 08/12/2014

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: 08/12/2014
• Initial Date FDA Received: 09/05/2014
• 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
• Patient Sequence Number: 1