MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA 560 HEMATOLOGY SYSTEM

Model Number	ADVIA 560 HEMATOLOGY SYSTEM
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A sample barcode was misread on an advia 560 hematology system with an autoloader.Siemens is investigating the issue.
Event or Problem Description
A sample barcode was misread on an advia 560 hematology system with an autoloader.Patient sample identification number (sid) (b)(6) was misread as sid (b)(6).There was no other patient sample with the sid (b)(6).Initial results were not reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to this event.
Additional Manufacturer Narrative
Siemens filed the initial mdr 2432235-2019-00410 on 08-nov-2019.Additional information (22-nov-2019): the customer did not provide additional information.The cause of the event could not be established.Potential causes of the event 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.

• Brand Name: ADVIA 560 HEMATOLOGY SYSTEM
• Common Device Name: ADVIA 560 HEMATOLOGY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown NY 10591
• MDR Report Key: 9295311
• Report Number: 2432235-2019-00410
• Device Sequence Number: 16734386
• Product Code: GKZ
• UDI-Device Identifier: 00630414601816
• UDI-Public: 00630414601816
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K112755
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2019

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
• Operator of Device: Health Professional
• Device Model Number: ADVIA 560 HEMATOLOGY SYSTEM
• Device Catalogue Number: 11170842
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/16/2019
• Supplement Date Received by Manufacturer: 11/22/2019
• Initial Report FDA Received Date: 11/08/2019
• Supplement Report FDA Received Date: 12/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1