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

Model Number ADVIA 1800

Device Problem Mechanical Problem (1384)

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

Event Date 09/27/2017

Event Type  malfunction  

Manufacturer Narrative

The customer contacted the siemens customer care center (ccc).A siemens customer service engineer (cse) was dispatched to the customer site.After analyzing the instrument, the cse performed total service visit on the instrument.The cse observed debris which appeared as a cloth material, partially aspirated into the plasma protein diluent (dpp) and hanging on the outside bottom of the sample probe.The cse cleared the debris and cleaned the probe.The cse checked all dispenses and ensured they were free of obstructed materials.The cse ran precision testing and quality control (qc), resulting within specification.The cause of the discordant, falsely low glucose result is associated with an obstructed probe caused by debris.The instrument is performing according to specifications.No further evaluation of the device is required.

Event Description

A discordant, falsely low glucose (glu) result was obtained on an advia 1800 instrument.The discordant result was not reported to the physician(s).The sample was repeated on an alternate advia instrument, resulting higher.The repeated result was reported to the physician(s).There are no reports of patient intervention or adverse health consequences due to the discordant, low glu result.

• Brand Name: ADVIA 1800
• Type of Device: CLINICAL CHEMISTRY ANALYZER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): JEOL LTD.; registration # 3003637681; 3-1-2 musashino akishima; tokyo 96-8558, ja
• Manufacturer Contact: margarita karan ; 511 benedict avenue; tarrytown, NY 10591 ; 9145243105
• MDR Report Key: 6969295
• MDR Text Key: 90784714
• Report Number: 2432235-2017-00565
• Device Sequence Number: 0
• Product Code: CFR
• 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 faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ADVIA 1800
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/28/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/17/2000
• Is the Device Single Use?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1