MAUDE Adverse Event Report: AGFA HEALTHCARE N.V. ENTEPRISE IMAGING FOR RADIOLOGY

Model Number EI 8.1 SP2

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/15/2017

Event Type  malfunction  

Event Description

On november 14, 2017, agfa was contacted by (b)(6) from (b)(6) about an event that had occurred (b)(6) 2017 while viewing studies in the clinical side bar of agfa's enterprise imaging client.The customer had reported to nhs that they realized on (b)(6) 2017, that a patient's images had been misinterpreted by the radiologist approximately five months earlier.Investigation by agfa and the customer revealed on (b)(6) 2017, a patient underwent a ct pulmonary angiogram (ctpa) during a hospitalization for a lower respiratory tract infection.The ctpa showed no evidence of pulmonary embolism.Note that this patient was also diagnosed with pleural adenocarcinoma of the lung in (b)(6) 2017.The cancer was treatable, but not curable, with a life expectancy of 9 to 20 months.On (b)(6) 2017, the same patient was admitted to the hospital with increasing shortness of breath.Another cpta was performed and reported on (b)(6) 2017 as being similar to that from (b)(6) 2017, with no evidence of acute pulmonary thromboembolism.The patient was diagnosed with a worsening of their existing copd (chronic obstructive pulmonary disease) and was treated accordingly.The patient was not taking anti-coagulants at this time.On (b)(6) 2017, the patient had a thorax, abdomen, and pelvis ct scan taken to assess the effects of chemotherapy.It was reported on september 12, 2017 and on september 13, 2017, an addendum was added to the (b)(6) 2017 report, indicating the images had been misinterpreted and the scan did, in fact, show multiple pulmonary emboli.The radiologist who reported the (b)(6) 2017 scan mistakenly looked at the images from the (b)(6) 2017, scan and reported based on those instead of the correct images.This was not reported to agfa healthcare at this time.On april 20, 2018, agfa was contacted by the customer requesting input into the root cause investigation of the above described event.After reviewing the sequence of this overall event, agfa opened complaint (b)(4) to assess for clinical risk and also opened nonconformity (b)(4) to address insufficient complaint documentation.The primary root cause was identified as customer misuse.The customer had received training and was made aware of this issue and that they may need to sort out prior studies in proper date sequence.In may 2017, the issue was assessed by an agfa healthcare clinical analyst as posing no risk to patient health.Additional root cause was a known issue which triggers a change of the sort order of the studies in the clinical side bar (csb).The issue was corrected in enterprise imaging 8.1.1.The customer reported in this event received this correction on july 27, 2017.After reviewing this event, agfa opened complaint (b)(4) to assess the clinical risk for the event and also opened nonconformity (b)(4) to address insufficient complaint documentation.There has been no reported harm to patient or user during this event.

Event Description

This update is being provided to clarify the patient consequences.User error has led to a misdiagnosis and resulted in the affected patient to have delayed therapy for her pulmonary emboli.Based on agfa's conclusion, user error is the primary cause of the injury.The misdiagnosis cannot be solely attributed to the incorrect ordering of prior and current studies on the csb.

• Brand Name: ENTEPRISE IMAGING FOR RADIOLOGY
• Type of Device: ENTEPRISE IMAGING
• Manufacturer (Section D): AGFA HEALTHCARE N.V.; septestraat 27; mortsel, B2640 ; BE B2640
• MDR Report Key: 7492718
• MDR Text Key: 108144242
• Report Number: 9616389-2018-00006
• Device Sequence Number: 1
• Product Code: LLZ
• Combination Product (y/n): N
• PMA/PMN Number: K142316
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 05/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Radiologic Technologist
• Device Model Number: EI 8.1 SP2
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/14/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1