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

Model Number	ADVIA 560 HEMATOLOGY SYSTEM
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/25/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted a siemens customer care center (ccc) and reported that a discordant, falsely low red blood cell (rbc) result was obtained on an advia 560 hematology system.Siemens analyzed the instrument data and determined the first sample aspiration shows multiple sample and system flags, and many of these are related to the rbc parameter (anemia, hyperchromic and macrocytic rbc).As per the advia 560 hematology system operator's guide, these flags should cause the operator to question and review the results, which the customer did in this case.No system problem was identified.The probable cause cannot be identified in this case, but pre-analytical factors cannot be ruled out.The system is performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
A discordant, falsely low red blood cell (rbc) result was obtained on an advia 560 hematology system.The discordant result was not reported to the physician(s).The sample was rerun twice for rbc, and both repeat results recovered higher.The repeat results were reported, as the correct results, to the physician(s).There are no reports of patient intervention or adverse health consequences due to the discordant, falsely low rbc result.

• 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
• MDR Report Key: 9793427
• Report Number: 2432235-2020-00225
• Device Sequence Number: 2920984
• 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
• Report Date (Section B): 03/05/2020

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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/10/2020
• Initial Report FDA Received Date: 03/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1