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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW STRATUS CS STAT FLUOROMETRIC ANALYZER

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SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW STRATUS CS STAT FLUOROMETRIC ANALYZER Back to Search Results
Catalog Number 10444834
Device Problem Computer Software Problem (1112)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/17/2016
Event Type  malfunction  
Manufacturer Narrative
Siemens is in process of issuing an urgent field safety notice to notify all affected customers and updating existing software to resolve the issue.
 
Event Description
Siemens internally found that a testpak can be tested on the instrument regardless of the status of calibration and/or quality control if it is within the 48 hour window of lot expiry. A message is displayed next to the testpak lot number on screen alerting the customer that the testpak will expire within 48 hours. This message overwrites any other flags or messages that should be displayed when running a sample during the last 48 hours of use life. Siemens has not received any external complaint for the issue. There was no report of injury due to this issue.
 
Manufacturer Narrative
Siemens healthcare is currently developing software updates to address this issue. Additional data: siemens issued an urgent field safety notice (poc 16-019. A. Us) to notify all the affected customers in june 2016.
 
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Brand NameSTRATUS CS STAT FLUOROMETRIC ANALYZER
Type of DeviceSTRATUS CS
Manufacturer (Section D)
SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW
glasgow business community
newark DE 19702
Manufacturer (Section G)
SIEMENS HEALTHCARE DIAGNOSTICS INC
62 flanders-bartley rd.
flanders NJ 07836
Manufacturer Contact
steven andberg
2 edgewater drive
norwood, MA 02062
7812693655
MDR Report Key5725827
MDR Text Key47417595
Report Number1217157-2016-00065
Device Sequence Number1
Product Code JHX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K984067
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation Other Health Care Professional
Remedial Action Other
Type of Report Initial,Followup
Report Date 06/23/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/15/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other Health Care Professional
Device Catalogue Number10444834
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/22/2016
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown
Removal/Correction Number1217157-06-17-2016-001-C

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