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

Model Number	ADVIA 560 HEMATOLOGY SYSTEM
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted a siemens customer care center (ccc) and reported that a discordant, falsely elevated hemoglobin result was obtained on a patient sample on an advia 560 hematology system (serial number: (b)(4)).Calibration and quality controls (qc) were acceptable on the day of the discordant, falsely elevated hemoglobin result.Siemens has requested the advia 560 hematology system instrument files from the affected instrument to investigate the issue.Siemens is investigating the issue.
Event or Problem Description
A discordant, falsely elevated hemoglobin result was obtained on a patient sample on an advia 560 hematology system (serial number: (b)(4)).The same sample was repeated for both total hemoglobin and cellular hemoglobin using an advia 2120i hematology system, both resulting lower.The repeat results were reported, as the correct results, to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely elevated hemoglobin result.
Additional Manufacturer Narrative
Siemens filed the initial mdr 2432235-2019-00232 on 09-jul-2019.Additional information (07-aug-2019): siemens further investigated the issue.Quality controls (qc) were within range at the time of the event.The samples were flagged with warning and interpretive flags, and the samples were rerun on an alternate system.The hyperchromic flag present should have triggered a review of the hemoglobin results by the laboratory.These flags are listed in the advia 560 operators guide, smn 11170869 rev.A, 2015-04, appendix b.Result code and conclusion code in section h6 were updated based on the additional information.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 ave; tarrytown NY 10591
• MDR Report Key: 8771321
• Report Number: 2432235-2019-00232
• Device Sequence Number: 11244227
• Product Code: GKZ
• UDI-Device Identifier: 00630414601816
• UDI-Public: 00630414601816
• Combination Product (Y/N): N
• Initial Reporter Country: ID
• 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): 08/30/2019

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: 06/14/2019
• Supplement Date Received by Manufacturer: 08/07/2019
• Initial Report FDA Received Date: 07/09/2019
• Supplement Report FDA Received Date: 08/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1