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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA 560 HEMATOLOGY SYSTEM
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SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA 560 HEMATOLOGY SYSTEM Back to Search Results
Model Number ADVIA 560 HEMATOLOGY SYSTEM
Device Problem Insufficient Information (3190)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/16/2019
Event Type  malfunction  
Manufacturer Narrative
A sample barcode was misread on an advia 560 hematology system with an autoloader.Siemens is investigating the issue.
 
Event Description
A sample barcode was misread on an advia 560 hematology system with an autoloader.Patient sample identification number (sid) (b)(6) was misread as sid (b)(6).There was no other patient sample with the sid (b)(6).Initial results were not reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to this event.
 
Manufacturer Narrative
Siemens filed the initial mdr 2432235-2019-00410 on 08-nov-2019.Additional information (22-nov-2019): the customer did not provide additional information.The cause of the event could not be established.Potential causes of the event include the customer barcode quality, or that barcode reader programming is needed to accommodate the customer's barcode symbology.The system is performing according to specifications.No further evaluation of this device is required.
 
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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 Key9295311
MDR Text Key219565810
Report Number2432235-2019-00410
Device Sequence Number1
Product Code GKZ
UDI-Device Identifier00630414601816
UDI-Public00630414601816
Combination Product (y/n)N
PMA/PMN Number
K112755
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Type of Report Initial,Followup
Report Date 12/13/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/08/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberADVIA 560 HEMATOLOGY SYSTEM
Device Catalogue Number11170842
Was Device Available for Evaluation? No
Date Manufacturer Received11/22/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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