MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC ADVIA 120 HEMATOLOGY SYSTEM WITH AUTOSAMPLER

Model Number ADVIA 120 HEMATOLOGY SYSTEM WITH AUTOSAMPLER

Device Problem Computer Software Problem (1112)

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

Event Date 02/01/2019

Event Type  malfunction  

Manufacturer Narrative

A customer contacted the siemens customer care center (ccc).Siemens reviewed the files that were provided by the customer.A siemens customer service engineer (cse) was dispatched to the account.The cse went onsite and verified that the advia 120 hematology system with autosampler was operating as expected with no performance issues found.The cse determined that the customer's newly installed non-siemens lis interface software potentially caused the incorrect patient names and sid's being assigned to the samples.The customer has since reported that the problem is still occurring.The customer also confirmed that the root cause of the issue has been identified.The non-siemens lis needs to adjust the timing on the orders.The customer is not using the autosampler mode until the timing is adjusted.The advia 120 hematology system with autosampler is performing within specifications.No further evaluation of the device is required.

Event Description

The customer reported that the incorrect patient name and sid had been assigned to seven out of twelve patient samples that were run using the advia 120 hematology system with autosampler.None of these results were reported to the physician.The same twelve samples were rerun in manual mode on the same day and were all assigned the correct patient names and sid's.The repeat results were reported to the physician.The customer did not consider any of the initial or rerun cbc results to be discordant.There are no known reports of patient intervention or adverse health consequences due to the incorrectly assigned patient names and sid's.

• Brand Name: ADVIA 120 HEMATOLOGY SYSTEM WITH AUTOSAMPLER
• Type of Device: ADVIA 120 HEMATOLOGY SYSTEM WITH AUTOSAMPLER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD; registration number: 8020888; chapel lane, swords, co.; dublin, ; EI
• Manufacturer Contact: christopher aebig ; 511 benedict ave; tarrytown, NY 10591 ; 9145242740
• MDR Report Key: 8376020
• MDR Text Key: 139350257
• Report Number: 2432235-2019-00066
• Device Sequence Number: 1
• Product Code: GKZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K971998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ADVIA 120 HEMATOLOGY SYSTEM WITH AUTOSAMPLER
• Device Catalogue Number: 10310973
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/01/2019
• Initial Date FDA Received: 02/27/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/02/2008
• 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