STRATUS CS 10444834

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-04-20 for STRATUS CS 10444834 manufactured by Siemens Healthcare Diagnostics Inc - Glasgow.

Event Text Entries

[43996621] Customer has been asked to provide message logs and extended calibrations print out to evaluate the event. The root cause of the event is unknown.
Patient Sequence No: 1, Text Type: N, H10


[43996622] Customer reported discrepancy between troponin results on stratus cs analyzer. There was no report of injury due to the event.
Patient Sequence No: 1, Text Type: D, B5


[46482870] Siemens field service engineer reviewed and evaluated customer provided print outs. There were no irregularities identified. Customer has not had any further issues with the instrument.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1217157-2016-00043
MDR Report Key5591113
Date Received2016-04-20
Date of Report2016-05-19
Date of Event2016-03-30
Date Mfgr Received2016-05-11
Date Added to Maude2016-04-20
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationMEDICAL TECHNOLOGIST
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactSTEVEN ANDBERG
Manufacturer Street2 EDGEWATER DRIVE
Manufacturer CityNORWOOD MA 02062
Manufacturer CountryUS
Manufacturer Postal02062
Manufacturer Phone7812693655
Manufacturer G1SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW
Manufacturer StreetGLASGOW BUSINESS COMMUNITY
Manufacturer CityNEWARK DE 19702
Manufacturer CountryUS
Manufacturer Postal Code19702
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSTRATUS CS
Generic NameSTRATUS CS
Product CodeDAP
Date Received2016-04-20
Catalog Number10444834
OperatorOTHER HEALTH CARE PROFESSIONAL
Device Availability*
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerSIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW
Manufacturer AddressGLASGOW BUSINESS COMMUNITY NEWARK DE 19702 US 19702


Patients

Patient NumberTreatmentOutcomeDate
10 2016-04-20

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