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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. - GLASGOW STRATUS CS

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SIEMENS HEALTHCARE DIAGNOSTICS INC. - GLASGOW STRATUS CS Back to Search Results
Catalog Number 10453571
Device Problem Use of Device Problem (1670)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/29/2016
Event Type  No Answer Provided  
Manufacturer Narrative
Siemens issued an urgent field safety notice (# poc 16-019. A. Ous) in june 2016 informing customers of a software defect in the stratus cs acute care diagnostics system regarding testpak calibration and quality control (qc) status when a testpak is due to expire within 48 hours. As stated in the "actions to be taken by the customer" section of the urgent field safety notice: do not use testpaks that are due to expire within 48 hours. The customer acknowledged that they received the urgent field safety notice prior to this event. The customer reported that the testpak lot has been discarded.
 
Event Description
The customer reported that they calibrated a ctni testpack that was about to expire and got an "*****above assay range" error message when a sample was run. There was no report of injury due to this event.
 
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Brand NameSTRATUS CS
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. - GLASGOW
glasgow business community
newark DE 19702
Manufacturer Contact
steven andberg
2 edgewater drive
norwood, MA 02062
7812693655
MDR Report Key6141235
MDR Text Key61603266
Report Number3002637618-2016-00159
Device Sequence Number1
Product Code JHX
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K984067
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation
Remedial Action Recall
Type of Report Initial
Report Date 12/02/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/02/2016
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number10453571
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/09/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Removal/Correction NumberZ-2525-2016

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