MAUDE Adverse Event Report: NANOSTRING TECHNOLOGIES, INC. PROSIGNA; CLASSIFIER, PROGNOSTIC, RECURRENCE RISK ASSESSMENT, RNA GENE EXPRESSION, BREAST

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

Event Type  Injury  

Event Description

Nano[invalid]products branded as veracyte don't work.

• Brand Name: PROSIGNA
• Type of Device: CLASSIFIER, PROGNOSTIC, RECURRENCE RISK ASSESSMENT, RNA GENE EXPRESSION, BREAST
• Manufacturer (Section D): NANOSTRING TECHNOLOGIES, INC.
• MDR Report Key: 17855426
• MDR Text Key: 324809806
• Report Number: MW5146345
• Device Sequence Number: 1
• Product Code: NYI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 09/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Life Threatening