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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 10453531
Device Problem Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/29/2016
Event Type  No Answer Provided  
Manufacturer Narrative
Customer was requested to return the samples if available for investigation. Customer indicated that they did not have samples as it had past stability time. Siemens requested to provide instrument log files to evaluate the event. The root cause for the event is unknown.
 
Event Description
Customer reported discordant troponin results on the analyzer. There was no report of injury due to this issue.
 
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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 flandres-bartley rd.
flanders NJ 07836
Manufacturer Contact
steven andberg
2 edgewater drive
norwood, MA 02062
7812693655
MDR Report Key5846816
MDR Text Key52409674
Report Number1217157-2016-00082
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
Type of Report Initial
Report Date 08/04/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/04/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other Health Care Professional
Device Catalogue Number10453531
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/08/2016
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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