MAUDE Adverse Event Report: GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING XELERIS WORKSTATION; SYSTEM,TOMOGRAPHY,COMPUTED,EMISSION

Model Number NX4WFS

Device Problems Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Renal Failure (2041)

Event Date 06/14/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Ge healthcare's investigation is ongoing.A follow-up report will be submitted when the investigation is complete.Device evaluation anticipated, but not yet begun.

Event Description

It was reported that a patient sustained a potential false negative issue due to an inaccurate interpretation of the kidney function number with deterioration in renal function for a patient with known kidney disease.

Manufacturer Narrative

The customer reported that in their department they used the wrong value for renal function in their report, which can lead to a misdiagnosis and specifically in this case as reported by the customer, a delay in the treatment to preserve renal function.The kidney function report was mistakenly derived from the relative perfusion value rather than relative uptake value, calculated and displayed in the renal analysis application.A trained and qualified nuc med physician would know the meaning of the uptake and perfusion values, as it is a standard procedure in the nuc med guideline and publications and will therefore know how to interpret and use them.Thus, the investigation concluded that the root cause of the issue is a use error reading and interpreting the relative values calculated and correctly displayed to the user.No system malfunction occurred.The investigation concluded that the sole root cause is a use error and no process root cause was identified.

• Brand Name: XELERIS WORKSTATION
• Type of Device: SYSTEM,TOMOGRAPHY,COMPUTED,EMISSION
• Manufacturer (Section D): GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING; 4 hayozma st.; tirat hacarmel 30200 ; IS 30200
• MDR Report Key: 8122337
• MDR Text Key: 129019578
• Report Number: 9613299-2018-00002
• Device Sequence Number: 1
• Product Code: KPS
• Combination Product (y/n): N
• PMA/PMN Number: K153355
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 01/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: NX4WFS
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 11 YR