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

Model Number ADVIA 1800

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 03/08/2015

Event Type  malfunction  

Event Description

Discordant chloride (cl) results were obtained on two 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 as expected.It is unknown if the repeat 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) specialist was dispatched to the customer site.The cse evaluated the instrument and performed a warm water wash through the ion selective electrode path and installed a new chloride electrode from a different lot.The cse ran precision testing, calibration, quality controls and two replicates of five patient samples, all of which were acceptable.The cause of the discordant cl results on two patient samples was related to the chloride electrode malfunction.This 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 # 3003637681); 3-1-2 musashino akishima; tokyo, 196- 8558; JA 196-8558
• Manufacturer Contact: michael metz ; 511 benedict avenue; tarrytown, NY 10591 ; 9145242223
• MDR Report Key: 4650099
• MDR Text Key: 21770488
• Report Number: 2432235-2015-00164
• 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: 03/08/2015

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: 03/08/2015
• Initial Date FDA Received: 04/01/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1