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

Model Number ADVIA CHEMISTRY XPT

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

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

Event Date 05/09/2017

Event Type  malfunction  

Manufacturer Narrative

A siemens headquarter support center (hsc) specialist reviewed the instrument data and concluded there is no method or reagent lot issue.The data indicated the issues with ca outliers is due to water integrity issues consistent with poor water quality.Siemens customer service engineers installed a new deionized water (di h20) in response to the on-going water issue.The cause of the erratic ca_2c results is associated with water integrity issues.The instrument is performing according to specifications.No further evaluation of the device is required.

Event Description

The customer reported erratic calcium 2, concentrated reagents (ca_2c) results on the advia 1800 clinical chemistry instrument following water system maintenance.The initial results were not reported to the physician(s).The samples were repeated.However, the customer did not provide any data for the initial or repeated ca_2c results.There are no known reports of patient intervention or adverse health consequences due to the discordant ca_2c results.

• Brand Name: ADVIA CHEMISTRY XPT
• Type of Device: CLINICAL CHEMISTRY ANALYZER,
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; 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: 6693101
• MDR Text Key: 79272610
• Report Number: 2432235-2017-00409
• Device Sequence Number: 0
• Product Code: CJY
• 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: 07/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2017
• 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: 06/14/2017
• 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