MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA 2400

Model Number ADVIA 2400

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 02/16/2017

Event Type  malfunction  

Manufacturer Narrative

A siemens customer service engineer (cse) and application specialist (as) were dispatched to the customer site.The cse verified the probe positions, probe priming, and functioning of the reaction cuvette washer (wud) and dilution cuvette washer (dwud).The cse then cleaned the wud and dwud with hypochlorite solution.The cse also checked the functioning of valves, system bottles and filters (cuvette conditioner, cuvette wash, water, and sodium chloride), and vertical pumps.The as checked the method setting.A siemens customer application specialist reviewed the instrument data and determined that in all cases, lipase was measured in the rotary reaction vessel cuvette prior to processing of crea_2.The cause of the discordant, falsely elevated crea_2 results on multiple patient samples is unknown.The instrument is performing within manufacturing specifications.No further evaluation of device is required.

Event Description

Discordant falsely elevated creatinine (crea_2) results were obtained on multiple patient samples on an advia 2400 instrument.The discordant results were not reported to the physician(s).The samples were repeated on the same instrument, resulting lower.The repeat results were reported to the physician(s).There are no reports of patient intervention or adverse health consequences due to the discordant, falsely elevated crea_2 results.

Manufacturer Narrative

The initial mdr 2432235-2017-00171 was filed on march 9, 2017.Additional information (04/19/2017): a siemens headquarters support center specialist reviewed the service report and suspected that there may have been contamination due to carryover from lipase in the rotary reaction vessel cuvette.After the siemens customer service engineer performed instrument maintenance and decontamination procedure, the issue resolved.

• Brand Name: ADVIA 2400
• Type of Device: ADVIA 2400
• 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 96-85 58; JA 96-8558
• Manufacturer Contact: margarita karan ; 511 benedict avenue; tarrytown, NY 10591 ; 9145243105
• MDR Report Key: 6393172
• MDR Text Key: 69572006
• Report Number: 2432235-2017-00171
• 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: 05/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2017
• 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: 04/19/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/21/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1