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

Model Number ADVIA CHEMISTRY XPT

Device Problems Mechanical Problem (1384); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 03/29/2017

Event Type  malfunction  

Manufacturer Narrative

The cause of the discordant, falsely elevated na results on patient samples is unknown.Siemens is investigating the issue.

Event Description

Discordant, falsely elevated sodium (na) results were obtained on patient samples on an advia chemistry xpt instrument.It is unknown if the initial results were reported to the physician(s).The samples were repeated on an alternate instrument and the results were in physiological range.The results obtained on the alternate instrument were reported to the physician(s).There are no reports of patient intervention or adverse health consequence due to the discordant, falsely elevated na results.

Manufacturer Narrative

The initial mdr 2432235-2017-00273 was filed on april 18, 2017.Additional information (03/30/2017): the customer stated that their calibrations and quality controls were acceptable at the time of event.A siemens customer service engineer (cse) was dispatched to the customer site.After analyzing the instrument, the cse replaced the baseline solution valve.The cse ran calibration and quality controls and performed coefficient of variation check, which were acceptable.A siemens headquarters support center (hsc) specialist reviewed the service report and concluded that the cause of the issue was due to the malfunction of ion-selective electrode (ise) baseline solution valve.The hsc specialist stated that if the baseline solution valve fails, then no baseline solution will be dispensed to the dilution bowl which can cause erroneous results.The issue was resolved by replacing the baseline solution valve.The instrument is performing within manufacturing specifications.No further evaluation of device is required.Additional information (05/05/2017): the initial mdr stated "it is unknown if the initial results were reported to the physician(s)." this information has been received and been updated.

Event Description

The initial results were not reported to the physician(s).

• Brand Name: ADVIA CHEMISTRY XPT
• 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, 196-8 558; JA 196-8558
• Manufacturer Contact: margarita karan ; 511 benedict avenue; tarrytown, NY 10591 ; 9145243105
• MDR Report Key: 6501129
• MDR Text Key: 73095091
• Report Number: 2432235-2017-00273
• Device Sequence Number: 0
• Product Code: JGS
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 05/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ADVIA CHEMISTRY XPT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/30/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/17/2015
• 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