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

Model Number ADVIA 560 HEMATOLOGY SYSTEM

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 11/07/2019

Event Type  malfunction  

Manufacturer Narrative

The customer contacted a siemens customer care center (ccc) and reported that discordant hemoglobin (hgb), hematocrit (hct), red blood cells (rbc), and red cell distribution width (rdw) results were obtained on patient samples on an advia 560 hematology system.Siemens is investigating the issue.

Event Description

Discordant hemoglobin (hgb), hematocrit (hct), red blood cells (rbc), and red cell distribution width (rdw) results were obtained on patient samples on an advia 560 hematology system compared to results generated on the lab's advia 2120i hematology system.The discordant results were not reported to the physician(s).The hgb, hct, rbc, and rdw results obtained on the lab's advia 2120i hematology system were considered correct.There are no reports of patient intervention or adverse health consequences due to the discordant hemoglobin (hgb), hematocrit (hct), red blood cells (rbc), and red cell distribution width (rdw) results.

Manufacturer Narrative

Siemens filed the initial mdr 2432235-2019-00442 on 04-dec-2019.Additional information (06-jan-2020): a siemens customer service engineer (cse) was dispatched to the customer site.The cse replaced the system amplifier board as well as the red blood cell (rbc) measure chamber.After the parts were installed, the cse checked the system electronics and pneumatics, both of which were acceptable.The probable cause of the event was a sample specific issue; however, siemens cannot rule out the two replaced parts as a possible cause of the event.The cause of the event is unknown.The system is performing according to specifications.No further evaluation of this device is required.

• Brand Name: ADVIA 560 HEMATOLOGY SYSTEM
• Type of Device: ADVIA 560 HEMATOLOGY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown NY 10591
• MDR Report Key: 9412092
• MDR Text Key: 195073779
• Report Number: 2432235-2019-00442
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 00630414601816
• UDI-Public: 00630414601816
• Combination Product (y/n): N
• PMA/PMN Number: K112755
• 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: 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
• Device Operator: Health Professional
• Device Model Number: ADVIA 560 HEMATOLOGY SYSTEM
• Device Catalogue Number: 11170842
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/08/2019
• Initial Date FDA Received: 12/04/2019
• Supplement Dates Manufacturer Received: 01/06/2020
• Supplement Dates FDA Received: 01/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1