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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. STRATUS CS
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SIEMENS HEALTHCARE DIAGNOSTICS INC. STRATUS CS Back to Search Results
Catalog Number 10444834
Device Problem False Positive Result (1227)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/06/2024
Event Type  malfunction  
Event Description
The customer reported that their stratus cs instrument gave a false positive troponin (ctni) result compared to repeat testing of the same sample on the same instrument.There is no report of injury due to this event.
 
Manufacturer Narrative
Siemens has requested more information and instrument files for further investigation.Investigation will commence once requested data has been received.The cause of this event is unknown.
 
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Brand Name
STRATUS CS
Type of Device
STRATUS CS
Manufacturer (Section D)
SIEMENS HEALTHCARE DIAGNOSTICS INC.
511 benedict avenue
tarrytown NY 10591
Manufacturer (Section G)
SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD.
northern road
chilton industrial estate
sudbury, suffolk CO10 2XQ
UK   CO10 2XQ
Manufacturer Contact
felix akinrinola
2 edgewater drive
norwood, MA 02062
MDR Report Key18797827
MDR Text Key337629161
Report Number3002637618-2024-00014
Device Sequence Number1
Product Code MMI
Combination Product (y/n)N
Reporter Country CodeSW
PMA/PMN Number
K051650
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 02/28/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/28/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number10444834
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/07/2024
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 Unknown
Patient Sequence Number1
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