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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC.STRATUS CS STAT FLUOROMETRIC ANALYZERACUTE 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  
Manufacturer Narrative

No further evaluation of the device is required. Analysis of the instrument and instrument data indicate that the cause for the falsely elevated troponin i result was heterophilic antibody. The ifu for stratus cs cctin testpak contains the following information: "patient samples may contain heterophilic antibodies that could react in immunoassays to give falsely elevated or depressed results. This assay has been designed to minimize interference from heterophilic antibodies. Nevertheless, complete elimination of this interference cannot be guaranteed. A test result that is inconsistent with the clinical picture and patient history should be interpreted with caution. " the instrument is performing within specifications.

 
Event Description

A falsely elevated troponin i result of 1. 74 ng/ml was obtained on a patient sample. The result was reported to the physician who questioned the result. The original sample was retested on alternate methodology and a result of 0. 00 ng/ml was obtained. Patient treatment was not prescribed or altered an there was no report of adverse health consequences as a result of the falsely elevated troponin i result. Analysis of the instrument and instrument data indicate the cause for the falsely elevated troponin i result was heterophilic antibody.

 
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Brand NameSTRATUS CS STAT FLUOROMETRIC ANALYZER
Type of DeviceACUTE CARE TROPONIN I TEST PAK
Manufacturer (Section F)
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
p.o. box 6101
newark DE 19714 6101
Manufacturer (Section D)
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
p.o. box 6101
newark DE 19714 6101
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
(302) 631 -8789
Device Event Key1040777
MDR Report Key1030271
Event Key988737
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
1 Patient Was 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
Device Age na
Was The Report Sent To Manufacturer? No
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
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Invalid Data

Patient TREATMENT DATA
Date Received: 04/15/2008 Patient Sequence Number: 1
#TreatmentTreatment Date
NA
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