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

Model Number	ADVIA 2120I WITH DUAL ASPIRATE AUTOSAMPLER
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A siemens customer service engineer (cse) was at a customer site and reported that a sample barcode was misread on an advia 2120i hematology system with dual aspirate autosampler by the system's hand held barcode reader during a manual sample barcode read.Siemens is investigating the issue.
Event or Problem Description
A siemens customer service engineer (cse) was at a customer site and reported that a sample barcode was misread on an advia 2120i hematology system with dual aspirate autosampler by the system's hand held barcode reader during a manual sample barcode read.Sid (b)(6) was misread as sid (b)(6).There are no known reports of patient intervention or adverse health consequences due to this event.
Additional Manufacturer Narrative
Siemens filed the initial mdr on 01-nov-2019.Additional information (15-nov-2019): due to no additional information received from the customer, further investigation of this issue is not possible and the cause of the event could not be established.Possible causes include the customer barcode quality, or that barcode reader programming is needed to accommodate the customer's barcode symbology.The system is performing according to specifications.No further evaluation of this device is required.
Additional Manufacturer Narrative
Siemens filed the initial mdr (b)(4) on (b)(6)2019.Siemens filed the first supplemental mdr 2432235-2019-00400_s1 on (b)(6)2019.Additional information (27-dec-2019): the customer contact name was provided.Section e1 of this report has been updated with this information.

• Brand Name: ADVIA 2120I WITH DUAL ASPIRATE AUTOSAMPLER
• Common Device Name: ADVIA 2120I WITH DUAL ASPIRATE AUTOSAMPLER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• MDR Report Key: 9266499
• Report Number: 2432235-2019-00400
• Device Sequence Number: 14021404
• Product Code: GKZ
• UDI-Device Identifier: 00630414560045
• UDI-Public: 00630414560045
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: K102644
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/09/2020

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
• Operator of Device: Other
• Device Model Number: ADVIA 2120I WITH DUAL ASPIRATE AUTOSAMPLER
• Device Catalogue Number: 10285573
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/10/2019
• Supplement Date Received by Manufacturer: 11/15/2019; 12/27/2019
• Initial Report FDA Received Date: 11/01/2019
• Supplement Report FDA Received Date: 12/06/2019; 01/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1