MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. STRATUS CS

Catalog Number	10444834
Medical Device Problem Code	Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that their stratus cs instrument produced a false positive troponin (ctni) result compared to retesting of the same sample on their laboratory instrument.There is no report of injury due to this event.
Additional Manufacturer Narrative
Siemens has requested more information and instrument files for further investigation.Investigation will commence once the requested data has been received.The cause of this event is unknown.
Additional Manufacturer Narrative
Mdr 3002637618-2024-00034 was filed on (b)(6)2024.Correction: (b)(6)2024 the mdr was initially incorrectly submitted as a 5-day initial report.Section g6 has been updated to reflect a 30-day report.
Additional Manufacturer Narrative
Siemens filed the initial mdr 3002637618-2024-00034 on 15-apr-2024.Siemens filed the first supplemental mdr 3002637618-2024-00034_s1 on 23-apr-2024.Additional information (16-may-2024): investigation has been completed.A review of the quality control data demonstrated the instrument, and reagents were working as intended.A review of the manufacturing release data for the lot in use at the time of the event.Demonstrated acceptable performance, nothing atypical was observed.The cause of this event is unknown.No product problem identified.The type of investigation, investigation findings, and investigatino conclusions codes in section h6 were updated per the additional information.The system is performing according to specifications.No further evaluation of this device is required.

• Brand Name: STRATUS CS
• Common Device Name: STRATUS CS
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): UPDATE ACCORDINGLY
• Manufacturer Contact: felix akinrinola ; 2 edgewater drive; norwood, MA 02062
• MDR Report Key: 19110926
• Report Number: 3002637618-2024-00034
• Device Sequence Number: 8230152
• Product Code: MMI
• UDI-Device Identifier: 00842768024863
• UDI-Public: 00842768024863
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 10444834
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2024
• Supplement Date Received by Manufacturer: 04/18/2024; 05/16/2024
• Initial Report FDA Received Date: 04/15/2024
• Supplement Report FDA Received Date: 04/23/2024; 06/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 17 YR
• Patient Sex: Male