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

Model Number ADVIA 1800

Device Problems False Device Output (1226); High Test Results (2457)

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

Event Date 06/05/2014

Event Type  malfunction  

Event Description

A discordant, falsely elevated chloride result was obtained on one patient sample on an advia 1800 instrument.The discordant chloride result was not reported to the physician(s).The sample was 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 result.

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 ion selective electrode (ise) module required cleaning.The cse cleaned the ise module and ran a precision test.The cause of the discordant chloride result is unknown.The cse successfully ran qc.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: 3904425
• MDR Text Key: 4430072
• Report Number: 2432235-2014-00401
• Device Sequence Number: 1
• Product Code: JJE
• 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: 06/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2014
• 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
• Date Manufacturer Received: 06/05/2014
• 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
• Removal/Correction Number: N/A
• Patient Sequence Number: 1