MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA 2120 HEMATOLOGY SYSTEM WITH SINGLE ASPIRATE AUTOSAMPLER

Model Number ADVIA 2120 HEMATOLOGY SYSTEM WITH SINGLE ASPIRATE AUTOSAMPLER

Device Problem Use of Device Problem (1670)

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

Event Date 08/23/2019

Event Type  malfunction  

Manufacturer Narrative

The customer contacted a siemens customer care center (ccc) and reported that one patient sample was registered incorrectly on the customer's data management system with the incorrect sample id when run on an advia 2120 hematology system with single aspirate autosampler.The patient sample was registered with the incorrect sample id by the lab secretary.The lab technician discovered that the incorrect sample id was used, and then corrected the sample id.This event occurred due to use error.The system is performing within specifications.No further evaluation of this device is required.

Event Description

The customer reported that one patient sample was registered incorrectly on the customer's data management system with the incorrect sample id when run on an advia 2120 hematology system with single aspirate autosampler.The sample was given a sample id from a different patient that had been tested the day before.The results obtained on the incorrectly labeled sample were sent to the host.The patient healthcare information (phi) for that patient was documented correctly in the data management system.The results were not reported to the physician(s).The patient sample was then rerun with the correct sample id, and these results were reported to the physician(s).The results obtained for the patient from the previous day were not impacted and the results were reported to the physician(s) with no issues observed.The are no reports of patient intervention or adverse health consequences due to the incorrectly assigned sample id.

• Brand Name: ADVIA 2120 HEMATOLOGY SYSTEM WITH SINGLE ASPIRATE AUTOSAMPLER
• Type of Device: ADVIA 2120 HEMATOLOGY SYSTEM WITH SINGLE ASPIRATE AUTOSAMPLER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; 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: 9008471
• MDR Text Key: 219784168
• Report Number: 2432235-2019-00320
• Device Sequence Number: 1
• Product Code: GKZ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K102644
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ADVIA 2120 HEMATOLOGY SYSTEM WITH SINGLE ASPIRATE AUTOSAMPLER
• Device Catalogue Number: 10374453
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/24/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/11/2006
• 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