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

Model Number ADVIA 1800

Device Problem Low Test Results (2458)

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

Event Date 12/22/2013

Event Type  malfunction  

Event Description

Discordant, falsely low chloride results were obtained on eight patient samples on an advia 1800 instrument.The discordant chloride results were reported to the physician(s).The customer repeated the samples and those results were reported to the physician(s).There are no reports of patient intervention or adverse health consequences due to the discordant, falsely low chloride results.

Manufacturer Narrative

A siemens healthcare diagnostics cse (customer service engineer) was dispatched to the customer site for instrument evaluation.After evaluating the instrument and data, the cse determined that the cause of the discordant chloride results was unknown.The cse removed and cleaned the ion selective electrode module, replaced the chloride electrode, performed calibration and ran qc.The instrument is performing within specifications.Further evaluation of the device is not required.

• 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, 3-1-2 MUSASHINO AKISHIMA,; registration number:3003637681; tokyo 196-8558; JA
• Manufacturer Contact: john nelson ; 511 benedict avenue; tarrytown, NY 10591 ; 9145242530
• MDR Report Key: 3582471
• MDR Text Key: 4035756
• Report Number: 2432235-2014-00131
• 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: 12/24/2013

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: 12/24/2013
• Initial Date FDA Received: 01/17/2014
• 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