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

Model Number ADVIA 2400

Device Problems False Device Output (1226); Incorrect Or Inadequate Test Results (2456)

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

Event Date 06/03/2014

Event Type  malfunction  

Event Description

A discordant, falsely elevated chloride (cl) result was obtained on one patient sample on an advia 2400 instrument.The discordant result was released to the pathologist(s), who questioned it.The sample was repeated on an alternate instrument, resulting lower.The corrected result was reported to the physician(s).There are no reports of patient intervention or adverse health consequences due to the discordant, falsely elevated cl result.

Manufacturer Narrative

The customer contacted the siemens technical solutions center (tsc).The customer stated that after replacing the ion selective electrode (ise) buffer, they did not perform ise calibrations prior to running patient samples.The customer re-calibrated the ise and ran quality controls, resulting within range.The cause of the discordant, falsely elevated cl result is a user error.The instrument is performing according to specifications.No further evaluation of the device is required.

• 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 number:3003637681; 3-1-2 musashino akishima; tokyo, 196- 8558; JA 196-8558
• Manufacturer Contact: cassandra kocsis ; 511 benedict avenue; tarrytown 10591 ; 9145242687
• MDR Report Key: 3898622
• MDR Text Key: 21489939
• Report Number: 2432235-2014-00382
• Device Sequence Number: 1
• Product Code: CGZ
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 06/04/2014

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 2400
• Device Catalogue Number: 073-A011-02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/04/2014
• Initial Date FDA Received: 06/26/2014
• 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