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

Model Number ADVIA CHEMISTRY XPT

Device Problem Mechanical Problem (1384)

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

Event Date 08/01/2017

Event Type  malfunction  

Manufacturer Narrative

The customer contacted the siemens customer care center (ccc) and stated that quality control (qc) was within range on the day the event occurred.A siemens customer service engineer (cse) was dispatched to the customer site.After inspecting the instrument, the cse replaced the dilution tray (dtt), reaction tray (rrv) cuvette and lamp.The cse performed cell blank and register lamp.The cse ran a shutdown wash.The cse ran qc, which passed.The cause of the discordant, falsely low lip result is unknown.The instrument is performing according to specifications.No further evaluation of the device is required.

Event Description

A discordant, falsely low lipase (lip) result was obtained on a patient sample on an advia chemistry xpt instrument.The discordant result was not reported to the physician(s).The sample was repeated on the same instrument, resulting higher.The repeated result was reported to the physician(s).There are no reports of patient intervention or adverse health consequences due to the discordant falsely low lip result.

• Brand Name: ADVIA CHEMISTRY XPT
• Type of Device: ADVIA CHEMISTRY XPT
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): JEOL LTD; registration number: 300363768; 3-1-2 musashino akishima; tokyo 196-8558, ; JA
• Manufacturer Contact: cassandra kocsis ; 511 benedict avenue; tarrytown, NY 10591 ; 9145242687
• MDR Report Key: 6835559
• MDR Text Key: 84362407
• Report Number: 2432235-2017-00491
• Device Sequence Number: 0
• Product Code: CHI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K990346
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 08/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 08/01/2017
• Initial Date FDA Received: 08/31/2017
• 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