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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. STRATUS CS STAT FLUOROMETRIC ANALYZER ACUTE CARE TROPONIN I TEST PAK

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SIEMENS HEALTHCARE DIAGNOSTICS, INC. STRATUS CS STAT FLUOROMETRIC ANALYZER ACUTE CARE TROPONIN I TEST PAK Back to Search Results
Catalog Number CCTNI
Event Date 03/15/2008
Event Type  Malfunction  
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Brand NameSTRATUS CS STAT FLUOROMETRIC ANALYZER
Type of DeviceACUTE CARE TROPONIN I TEST PAK
Manufacturer (Section D)
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
p.o. box 6101
newark DE 19714 610
Manufacturer (Section G)
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
p.o. box 6101
newark DE 19714
Manufacturer Contact
carolyn chastain
p.o. box 6101 - m/s 514
newark , DE 19714-6101
3026318789
MDR Report Key1030271
Report Number2517506-2008-00035
Device Sequence Number1
Product CodeMMI
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other Health Care Professional
Remedial Action Other
Type of Report Initial
Report Date 03/17/2008
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/15/2008
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date06/21/2008
Device Catalogue NumberCCTNI
Device LOT Number238021002
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received03/17/2008
Was Device Evaluated By Manufacturer? No
Date Device Manufactured01/21/2008
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data

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