MAUDE Adverse Event Report: GE MEDICAL SYSTEMS, LLC DISCOVERY MI; SYSTEM,TOMOGRAPHY,COMPUTED,EMISSION

Model Number PDBB01

Device Problems Improper or Incorrect Procedure or Method (2017); Application Program Version or Upgrade Problem (2881)

Patient Problem Misdiagnosis (2159)

Event Type  Injury  

Manufacturer Narrative

Unique identifier: (b)(4).Legal manufacturer: (b)(4).Ge healthcare's investigation into the reported occurrence is ongoing.A follow-up report will be issued when the investigation has been completed.

Event Description

It was reported that a patient's chemotherapy plan was de-escalated because comparative images were diagnosed as a false negative condition.Per customer communication on (b)(6) 2019, as a result of this altered treatment plan, her lymphoma has progressed.Ge healthcare's investigation into the reported occurrence is ongoing.A follow-up report will be issued when the investigation has been completed.

Manufacturer Narrative

-the main root cause is missing requirement for software control on dependent options existence.-additional root cause is related to incorrect assessment of the need for process validation of service fmi instructions as part of the fmi design change.-a supporting root cause is derived from incomplete software implementation, where a change to the preset parameters had been made without visual indication (either color highlighting or warning message).-a supporting root cause was use error: users (both technologist who generated the images and physicians who reviewed the images) did not follow qa procedures and therefore did not notice that recon method parameters were changed.

• Brand Name: DISCOVERY MI
• Type of Device: SYSTEM,TOMOGRAPHY,COMPUTED,EMISSION
• Manufacturer (Section D): GE MEDICAL SYSTEMS, LLC; 3000 n grandview blvd.; waukesha, WI 53188
• MDR Report Key: 9603809
• MDR Text Key: 176612127
• Report Number: 2126677-2020-00001
• Device Sequence Number: 1
• Product Code: KPS
• Combination Product (y/n): N
• PMA/PMN Number: K161574
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 03/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PDBB01
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other