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

Model Number	ADVIA 560 HEMATOLOGY SYSTEM
Medical Device Problem Code	Failure to Read Input Signal (1581)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/04/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside of the united states (ous) customer contacted a siemens customer care center (ccc).A siemens customer service engineer (cse) replaced the autoloader for the advia 560 hematology system and the problem did not occur again.No product non-conformance was observed for the autoloader.The cause of the event was limited to the initial autoloader and was resolved by replacing the autoloader.The system is performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
The customer reported an issue on their advia 560 hematology system where the autoloader would duplicate the barcode sent to the system from the tube in position 7 to the tube in position 8 of the autosampler rack.The results from the tube in position 8 would therefore be assigned to the incorrect patient.The rest of the tubes were read with the correct barcode.No patient results were reported to the physician(s) for the incorrect patient due to this issue.There are no known reports of patient intervention or adverse health consequences due to this event.

• Brand Name: ADVIA 560 HEMATOLOGY SYSTEM
• Common Device Name: ADVIA 560 HEMATOLOGY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave.; tarrytown NY 10591
• Manufacturer (Section G): DIATRON MI PIC; registration #: 3009297077; tablas str. 39; budapest, H-109 7; HU H-1097
• Manufacturer Contact: christopher aebig ; 511 benedict ave.; tarrytown, NY 10591 ; 9144153450
• MDR Report Key: 15685654
• Report Number: 2432235-2022-00292
• Device Sequence Number: 15077321
• Product Code: GKZ
• UDI-Device Identifier: 00630414601816
• UDI-Public: 00630414601816
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K112755
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/27/2022

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/04/2022
• Initial Report FDA Received Date: 10/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown