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

Model Number ADVIA 2120 HEMATOLOGY SYSTEM WITH DUAL ASPIRATE AUTOSAMPLER

Device Problem Patient Data Problem (3197)

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

Event Date 04/27/2020

Event Type  malfunction  

Manufacturer Narrative

The customer contacted a siemens customer care center (ccc).Siemens is investigating the issue.

Event Description

The customer contacted siemens and stated that advia 2120 hematology system with dual aspirate autosampler displayed demographics from the laboratory number used last year.There are no reports of patient intervention or adverse health consequences due to this event.

Manufacturer Narrative

The initial mdr 2432235-2020-00296 was filed on (b)(6)-2020.Additional information (29-may-2020): siemens investigation determined that the incorrectly displayed demographics was because the previous sample id (sid) from the patient had not been purged by the customer due to incorrect purge settings on the advia 2120i hematology system software.Siemens requested that the customer correct the settings and perform the end of day procedure from the advia 2120i hematology system operator's guide in order to purge sample ids (sids) greater than two days old from all categories, thus resetting all sids.The cause of the event is use error.The system is performing according to specifications.No further evaluation of this device is required.

• Brand Name: ADVIA 2120 HEMATOLOGY SYSTEM WITH DUAL ASPIRATE AUTOSAMPLER
• Type of Device: ADVIA 2120 HEMATOLOGY SYSTEM WITH DUAL ASPIRATE AUTOSAMPLER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave.; tarrytown, ny
• MDR Report Key: 10083090
• MDR Text Key: 203639670
• Report Number: 2432235-2020-00296
• Device Sequence Number: 1
• Product Code: GKZ
• Combination Product (y/n): N
• PMA/PMN Number: K102644
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 06/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2020
• 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 DUAL ASPIRATE AUTOSAMPLER
• Device Catalogue Number: 10313419
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1