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

Model Number ADVIA 1800

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/22/2014

Event Type  malfunction  

Event Description

Discordant chloride results were obtained on three patient samples on an advia 1800 instrument.The discordant chloride results were not reported to the physician(s).The samples were retested on an alternate instrument and those results were reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant chloride results.

Manufacturer Narrative

A siemens healthcare diagnostics cse (customer service engineer) was dispatched to the customer site for instrument evaluation.The cse replaced the mixor motor, cell base, seals and tubing 49 assembly.The cse ran qc successfully.The cause of the discordant chloride results is unknown.The instrument is performing within 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: 3630125
• MDR Text Key: 16007948
• Report Number: 2432235-2014-00177
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/22/2014

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: 01/22/2014
• Initial Date FDA Received: 02/17/2014
• 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
• Removal/Correction Number: N/A
• Patient Sequence Number: 1