Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. - GLASGOW STRATUS CS
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SIEMENS HEALTHCARE DIAGNOSTICS INC. - GLASGOW STRATUS CS Back to Search Results
Catalog Number 10453571
Device Problem False Positive Result (1227)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/20/2024
Event Type  malfunction  
Event Description
Customer reported that their stratus cs instrument produced discrepant troponin (ctni) result compared to repeat testing of a different sample on their laboratory instrument.Qc for date of event failed and was outside the normal range.There is no report of injury due to this event.
 
Manufacturer Narrative
Siemens has requested instrument files for investigation.Investigation is underway.Service went on-site to troubleshoot and found no hardware issues with the instrument.The cause of this event is unknown.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
STRATUS CS
Type of Device
STRATUS CS
Manufacturer (Section D)
SIEMENS HEALTHCARE DIAGNOSTICS INC. - GLASGOW
500 gbc drive
po box 6101
newark DE 19714
Manufacturer (Section G)
SIEMENS HEALTHCARE DIAGNOSTICS INC.
62 flanders-bartley rd.
flanders NJ 07836
Manufacturer Contact
felix akinrinola
2 edgewater drive
norwood, MA 02062
MDR Report Key18997227
MDR Text Key339220721
Report Number3002637618-2024-00025
Device Sequence Number1
Product Code MMI
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
K051650
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/28/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/28/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number10453571
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/20/2024
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 Reuse
Patient Sequence Number1
-
-