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

Model Number ADVIA 1800

Device Problems False Reading From Device Non-Compliance (1228); High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/17/2014

Event Type  malfunction  

Event Description

A discordant, falsely elevated chloride result was obtained on one patient sample on an advia 1800 instrument.It is unknown if the discordant result was reported to the physician(s).The sample was repeated on the same instrument after recalibration and resulted lower.It is unknown if the corrected result was reported to the physician(s).There are no reports of patient intervention or adverse health consequences due to the discordant chloride result.

Manufacturer Narrative

The customer contacted the siemens ccc.The customer stated that they had observed increased chloride values for patient samples.The customer ran quality controls (qc), which were within range but higher than the means.The customer recalibrated and repeated qc, which was then on the mean.Patient samples were repeated and the discordant result was discovered.The cause of the discordant chloride result is unknown.The instrument is performing according to specifications.No further evaluation of this 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: cassandra kocsis ; 511 benedict ave; tarrytown, NY 10591 ; 9145242687
• MDR Report Key: 4402400
• MDR Text Key: 5127979
• Report Number: 2432235-2015-00017
• Device Sequence Number: 1
• Product Code: CGZ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K990346
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 12/17/2014

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: Other
• 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: 12/17/2014
• Initial Date FDA Received: 01/09/2015
• 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