MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA 2400; CLINICAL CHEMISTRY ANALYZER

Model Number ADVIA 2400

Device Problem Insufficient Information (3190)

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

Event Date 02/06/2017

Event Type  malfunction  

Manufacturer Narrative

Siemens is investigating the event.

Event Description

A discordant, falsely elevated creatinine_2 result was obtained on a patient sample on an advia 2400 instrument.It is unknown if the initial result was reported out to the physician(s).The customer repeated the same sample on the same advia 2400 instrument, resulting lower.It is unknown which repeat result was reported out to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely elevated creatinine_2 results.

Manufacturer Narrative

The initial mdr 2432235-2017-00175 was filed on march 7, 2017.Additional information (05/08/2017): additional information showed that another mdr was filed for the advia 2400, serial number (b)(4).This mdr (2432235-2017-00175) is a duplicate mdr entry.For additional information, please see mdr 2432235-2017-00171.

• Brand Name: ADVIA 2400
• 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, japan 196-8 558; JA 196-8558
• Manufacturer Contact: timothy rice ; 511 benedict ave; tarrytown, NY 10591 ; 9145242406
• MDR Report Key: 6386200
• MDR Text Key: 69326865
• Report Number: 2432235-2017-00175
• Device Sequence Number: 0
• Product Code: CGX
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K990346
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ADVIA 2400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/08/2017
• 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