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

Catalog Number	10444834
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2024
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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.
Additional Manufacturer Narrative
Siemens has completed the investigation.The root cause was unable to be determined for the discrepant ctni result reported by the customer.A review of the error log along with the calibration and quality control data for the lot in use at the time of the event demonstrated the instrument and reagent were working as intended.A review of the manufacturing release data for lot 233303002 demonstrated acceptable performance, nothing atypical was observed.No product problem identified.
Additional Manufacturer Narrative
Siemens healthineers diagnostics has identified, through customer complaints, an increased occurrence of random non-repeatable false positive cardiac troponin (ctni) results at any point during the testpak¿s shelf life when using the stratus cs ctni acute care testpak.This means some ctni values for samples that are expected to fall within the 99th percentile of the reference population (per the instructions for use: 0.00 - 0.07 ng/ml [g/l]) may exceed this range.This issue can impact results.The stratus cs were confirmed to display false positive ctni results without alerting the user.The data revealed the maximum positive bias is 0.42 ng/ml with an average bias of 0.14 ng/ml when repeated on stratus scs platform.Siemens has released a field action (poc 25-006) "false positive ctni results for acute care ctni testpak" to inform customers of the issue and provide mitigation options.Crr#: 3002637618-03-31-2025-002-c.H6 c22: the issue was confirmed but the cause of the elevated rate of false positive ctni is unknown.

• 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): 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 Key: 18797827
• Report Number: 3002637618-2024-00014
• Device Sequence Number: 12574731
• Product Code: MMI
• UDI-Device Identifier: 00842768024863
• UDI-Public: 00842768024863
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K051650
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/02/2025

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: 02/07/2024
• Supplement Date Received by Manufacturer: 03/12/2024; 04/07/2025
• Initial Report FDA Received Date: 02/28/2024
• Supplement Report FDA Received Date: 04/11/2024; 05/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Unknown
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 3002637618-03-31-2025-00
• Patient Sequence Number: 1
• Patient Sex: Unknown