MAUDE Adverse Event Report: MERGE HEALTHCARE INCORPORATED RADSUITE; RADIOLOGICAL IMAGE PROCESSING SYSTEM

Model Number 8.30.7.8

Device Problems Incorrect Or Inadequate Test Results (2456); Device Operates Differently Than Expected (2913); Programming Issue (3014)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

A radiologist was reviewing a tumor case in radsuite and noticed that the pixel value tool was displaying different values then the pet modality's software.To aid in the interpretation of pet images, the pixel value tool within the radsuite software can be used to view the absorption of an injected isotope in body tissue based on standardized uptake values (suv).The patient weight value is used for calculating the suv.If the patient weight is missing, the value is null.If a study with a patient weight value of null is viewed after a study for a different patient with a patient weight value greater than 0, the weight from the previous study will be used to calculate the suvs for the study with the null weight value.This may result in incorrect suvs.If other clinical factors are not available or taken into due consideration, incorrect suvs could potentially lead to overstatement or understatement of the effectiveness of a cancer treatment, or to a misdiagnosis of a cancer.

• Brand Name: RADSUITE
• Type of Device: RADIOLOGICAL IMAGE PROCESSING SYSTEM
• Manufacturer (Section D): MERGE HEALTHCARE INCORPORATED; 900 walnut ridge drive; hartland WI 53029
• Manufacturer (Section G): MERGE HEALTHCARE INCORPORATED; 9099 walnut ridge drive; hartland WI 53029
• Manufacturer Contact: michael diedrick ; 900 walnut ridge drive; hartland, WI 53029 ; 2629123570
• MDR Report Key: 5305355
• MDR Text Key: 33709625
• Report Number: 2183926-2015-00005
• Device Sequence Number: 1
• Product Code: LLZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K053281
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 12/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 8.30.7.8
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/18/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/06/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1