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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS DNOTE CORE LICENSE
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SIEMENS HEALTHCARE DIAGNOSTICS DNOTE CORE LICENSE Back to Search Results
Catalog Number 10732537
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problem No Information (3190)
Event Date 03/20/2018
Event Type  malfunction  
Manufacturer Narrative
Siemens contacted the customer several times requesting additional information regarding this incident.The response from the customer was that they cannot provide any additional information on this issue.
 
Event Description
The customer reported that a patient's glucose result was incorrectly reported verbally and insulin was given when it should not have been.The result was not on the patient's chart due to a procedural change initiated by the customer that did not get updated in the data management system.
 
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Brand Name
DNOTE CORE LICENSE
Type of Device
DNOTE CORE LICENSE
Manufacturer (Section D)
SIEMENS HEALTHCARE DIAGNOSTICS
511 benedict avenue
tarrytown NY 10591
Manufacturer (Section G)
SIEMENS HEALTHCARE GMBH
albert-einstein-str. 14
berlin, 12489
GM   12489
Manufacturer Contact
steven andberg
2 edgewater drive
norwood, MA 02062
7812693655
MDR Report Key7429355
MDR Text Key105892750
Report Number3002637618-2018-00046
Device Sequence Number0
Product Code CFR
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation Other
Type of Report Initial
Report Date 04/13/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/13/2018
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number10732537
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received03/22/2018
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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