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

Model Number	ADVIA 560 HEMATOLOGY SYSTEM
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/07/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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
• Common Device Name: ADVIA 560 HEMATOLOGY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown NY 10591
• MDR Report Key: 9412092
• Report Number: 2432235-2019-00442
• Device Sequence Number: 16877505
• Product Code: GKZ
• UDI-Device Identifier: 00630414601816
• UDI-Public: 00630414601816
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 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: Health Professional
• Device Model Number: ADVIA 560 HEMATOLOGY SYSTEM
• Device Catalogue Number: 11170842
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/08/2019
• Supplement Date Received by Manufacturer: 01/06/2020
• Initial Report FDA Received Date: 12/04/2019
• Supplement Report FDA Received Date: 01/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1