MAUDE Adverse Event Report: AGFA HEALTHCARE CORP IMPAX CV OUTBOUND (RESULTS MANAGEMENT 2.08)

Model Number IMPAX CV 2.08

Device Problem Device Displays Incorrect Message (2591)

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

Event Date 11/13/2014

Event Type  malfunction  

Event Description

Agfa submitted mdr report #1225058-2010-00001 to the fda on june 7, 2010, for a site in the us.A 14th occurrence is being reported for the same issue/same device: impax cv results management administration tool (rmat).This is an internal discovery determined during the implementation of the associated problem correction plan, rmat verification, as reported in fda z-2112-10.Within this occurrence are 34 different study dates in which an individual mdr report will be submitted for each associated study date and medical record number/s (mrn) identified.

Manufacturer Narrative

An agfa clinical analyst performed a retro-analysis and reported the findings to agfa service and agfa product quality manager.Agfa's investigation into this occurrence of rmat customizations has revealed that this specific change had the potential to introduce clinical inaccuracies in patient reports.Specifically: the original sentence of: "the mean gradient of the aortic valve is" has been changed to: "there is severe aortic stenosis".In this issue, the intent of the reading physician is to describe the mean gradient measurement would be added to the notes section although there is nothing in the diff or the summary to provide evidence for that assumption.The sentence change however, changes the original intent from quantifying the av mean gradient to indicating the severity as is severe.This change is different clinically and would not reflect the intent of the original reading cardiologist as the mean gradient might not clinically indicate a diagnosis of severe as and could lead to misdiagnosis and/or inappropriate treatment.Potential impact: if the change was made after reports had been generated with the original sentence selected, those reports prior to the change could display incorrect clinical data if viewed in rm or if used as a template for a repeat study on that patient.There has been no reported patient harm for this occurrence.A reportable correction is underway for this issue and has been reported to the fda via reference #z-2112-10.Agfa will follow the rmat post market verification work instructions to correct the sentence finding.Any further investigation for the site described in this report will be documented in the ongoing cfr part 806 reporting.(b)(6).

• Brand Name: IMPAX CV OUTBOUND (RESULTS MANAGEMENT 2.08)
• Manufacturer (Section D): AGFA HEALTHCARE CORP; 1 crosswind rd.; misquamicut RI 02891
• Manufacturer Contact: deborah huff ; 10 south academy st; greenville, SC 29601 ; 8644211754
• MDR Report Key: 4681275
• MDR Text Key: 5693004
• Report Number: 1225058-2014-15454
• Device Sequence Number: 1
• Product Code: LLZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050228
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 12/12/2014

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: Other
• Device Model Number: IMPAX CV 2.08
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/13/2014
• Initial Date FDA Received: 12/12/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2002
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1