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 08/29/2017

Event Type  malfunction  

Manufacturer Narrative

The customer contacted a siemens customer care center.Quality controls were within acceptable range.A siemens customer service engineer (cse) was dispatched to the customer site.After analyzing the instrument, the cse changed the reagent 1 (r1) mixer motor which improved the precision, however, still showed precision issues due to micro bubbles in the dilution syringes.The cause of the discordant, falsely elevated ca_2c results on three patient samples is unknown.Siemens is investigating the issue.

Event Description

Discordant, falsely elevated calcium_2 concentrated (ca_2c) results were obtained on three patient samples on an advia chemistry xpt instrument.The discordant results were not reported to the physician(s).The samples were repeated on an alternate advia chemistry instrument, resulting lower and matching the clinical picture of the patients.The results obtained on the alternate advia chemistry instrument were reported to the physician(s).There are no reports of patient intervention or adverse health consequence due to the discordant, falsely elevated ca_2c results.

Manufacturer Narrative

The initial mdr was filed on september 19, 2017.Additional information (09/06/2017): a siemens regional support center (rsc) specialist was dispatched to the customer site.The issue started after the saline bottle was swapped with the cuvette wash bottle by the customer during routine maintenance.The rsc specialist performed precision checks on calcium_2 concentrated (ca_2c), ion-selective electrode (ise) and three other tests.The rsc specialist noted that the initial ca_2c results were elevated and the repeat results were low, however, other assays were not impacted.The rsc specialist also noted that ise exceeded analytical range errors on some ise results.The rsc specialist checked the system alignment, adjusted mixer 1, and realigned reagent tray 1 to reagent pump 1, as the probe was touching the reagent container inserts.The rsc specialist verified the performance of wash stations and reagent pumps and replaced 1mm seal on sampling pump as a precautionary measure.The rsc specialist repeated precision check and there was no improvement in ca_2c performance.The rsc specialist then replaced the mixer motor 1 and mixer paddle and repeated precision check for ca_2 c, which improved, however, precision was still not within specification.During a follow-up visit, the rsc specialist verified the performance of the dilution probe aspiration pump (dip), dilution probe discharge pump (dop) and dilution probe wash pump (dcp) and replaced 1mm dip pump seal as a precautionary measure.During priming, the rsc specialist noted bubbles in the dop which were traced back to the degasser module.The rsc specialist verified the connections on to the degasser module, drained the degasser module and removed approximately 20 ml of yellow foaming liquid.The rsc specialist determined that there may have been an internal leak in the degasser module.The rsc specialist also determined that the delivery issue with ise baseline solution may have exceeded analytical range errors on ise.The inspection of the ise baseline syringe showed debris in the syringe, which was potentially coming from the ise baseline seal.The rsc specialist replaced the ise baseline valve and seal and performed precision check, which was acceptable.A siemens customer service engineer (cse) was dispatched to the customer site.The cse replaced the degasser, however, bubbles still remained in the pumps.Further investigation revealed that the vacuum pump and tubing were contaminated with white grease like substance.The cse cleaned the tubing and replaced the vacuum pump, which resolved the issue.The rsc specialist concluded that the issue may have occurred due to the leak within the degasser module and damage of the vacuum pump, which supplies the vacuum for the degasser.The cause of leak may have been due to the prolonged exposure to cuvette wash solution when the cuvette wash and saline bottle caps were swapped during maintenance performed by the customer.The problem with the ise was a combination of failure of the ise baseline syringe seal and the ise base line valve as well as problems with the degasser.The instrument is performing within manufacturing specifications.No further evaluation of device is required.

• 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: karl aebig ; 511 benedict avenue; tarrytown, NY 10591 ; 9145243102
• MDR Report Key: 6877429
• MDR Text Key: 87328195
• Report Number: 2432235-2017-00516
• Device Sequence Number: 0
• Product Code: CJY
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 10/03/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2017
• 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: 09/06/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/15/2016
• 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