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

Model Number 7.0.2

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/02/2015

Event Type  malfunction  

Manufacturer Narrative

Investigation into the root cause of the problem is underway at the time of this report.

Event Description

The customer believes that the standardized uptake values (suv) measurements are not as accurate when the mpr is done using a 2d image.At the time of this report, the degree of inaccuracy and its clinical significance has not been confirmed.

Manufacturer Narrative

An investigation into the complaint from a customer who alleged that the standardized uptake value (suv) measurements are not as accurate when the mpr is done using a 2d image, has found that the suv measurements are accurate in 2d and 3d.Evidence to support this conclusion includes the following: a merge healthcare implementation engineer contacted the customer to obtain additional information and to see if the end user would have any examples of the allegation available.A web meeting was held with an engineer at merge and a physician at the complainant's facility.The physician completed suv measurements on the same pet/ct image using three different viewers: "normal" pacs viewer, the mpr single viewer and the mpr four panel viewer.The physician found all of the suv measurements were within approximately 1/10th of each other.The physician acknowledged that these measurements were acceptable for him and his practice.To ensure that the merge pacs product functions as expected, a merge senior software developer investigated the merge pacs suv calculation related code.The developer confirmed that the code functions as intended.Additionally, when a required suv variable such as patient weight, is not available in the study, a value of "n/a" is displayed for the measurement.The investigation into this complaint also determined that merge pacs was tested according to the quantitative imaging biomarkers alliance (qiba)/ radiological society of north america (rsna) digital reference object (dro) guidance.Merge healthcare has acknowledged this report and completed the suv calculations using the dro.All test data was found acceptable.In conclusion, merge healthcare's investigation into the alleged inaccurate suv measurements were most likely due to a user error.Merge pacs satisfies the rsna/qiba guidelines for suv measurements.The customer was able to confirm after additional research and calculations using 3 different viewers, that the suv measurements were within an acceptable range.Merge healthcare's investigation confirmed that this is not a device malfunction and there was no injury, potential injury or death.

• Brand Name: MERGE PACS
• Type of Device: RADIOLOGICAL IMAGE PROCESSING SYSTEM
• Manufacturer (Section D): MERGE HEALTHCARE; 900 walnut ridge drive; hartland WI 53029
• Manufacturer (Section G): MERGE HEALTHCARE; 900 walnut ridge drive; hartland WI 53029
• Manufacturer Contact: michael diedrick ; 900 walnut ridge drive; hartland, WI 53029 ; 2629123570
• MDR Report Key: 5339782
• MDR Text Key: 34885730
• Report Number: 2183926-2015-00034
• Device Sequence Number: 1
• Product Code: LLZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082144
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/03/2016

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
• Device Operator: Health Professional
• Device Model Number: 7.0.2
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/02/2015
• Initial Date FDA Received: 01/03/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/06/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/24/2012
• 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