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

Model Number ADVIA 560 HEMATOLOGY SYSTEM

Device Problem Failure to Read Input Signal (1581)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/04/2022

Event Type  malfunction  

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 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
• Type of Device: 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
• MDR Text Key: 307169473
• Report Number: 2432235-2022-00292
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 00630414601816
• UDI-Public: 00630414601816
• Combination Product (y/n): N
• Reporter Country Code: CI
• PMA/PMN Number: K112755
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 10/04/2022
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1