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

Catalog Number 10444834

Device Problem False Positive Result (1227)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/04/2024

Event Type  malfunction  

Event Description

Customer reported that their stratus cs instrument gave a false positive troponin result.Customer repeated the same sample on the same analyzer and received a negative result which the customer believed to be true.There is no report of injury due to this event.

Manufacturer Narrative

Siemens has requested more information and instrument files from the customer to perform further investigation.Investigation will commence once the requested data has been received.The cause of this event is unknown.

• Brand Name: STRATUS CS
• Type of Device: STRATUS CS
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 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 Key: 18702611
• MDR Text Key: 335355139
• Report Number: 3002637618-2024-00010
• Device Sequence Number: 1
• Product Code: MMI
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K051650
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 10444834
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/07/2024
• 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: A
• Patient Sequence Number: 1