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

Model Number ADVIA 1800

Device Problems False Device Output (1226); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/03/2014

Event Type  malfunction  

Event Description

Discordant, falsely low sodium (na) results were obtained on patient samples on an advia 1800 instrument.The discordant results were reported to the physician(s).The samples were repeated on an alternate instrument, resulting higher.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 low na results.

Manufacturer Narrative

The customer contacted the siemens customer care center (ccc).The customer stated to ccc that the issue was resolved by replacing the electrode.The cause of the discordant, falsely low na results was due to an electrode malfunction.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: 3974223
• MDR Text Key: 15816460
• Report Number: 2432235-2014-00460
• 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: Health Professional
• Type of Report: Initial
• Report Date: 07/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2014
• 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: 07/08/2014
• 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