MAUDE Adverse Event Report: AGFA HEALTHCARE CORPORATION IMPAX CV OUTBOUND (RESULTS MANAGEMENT 2.08); PICTURE ARCHIVING AND COMMUNICATION

Model Number IMPAX CV 2.08

Device Problem Incorrect Measurement (1383)

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

Event Date 10/03/2014

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 12th 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 12th occurrence are 2,828 different study dates from years 2005 to october 2014, in which an individual mdr report will be submitted for each associated study date and medical record number (mrn).Currently, 10,266 reports contain this incorrect finding information.

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 customization has revealed that this specific change had the potential to introduce clinical inaccuracies in patient reports.Specifically: echo r.1.1.1 - incorrect measurement sentence import: the sentence "the aortic valve area, by peak velocities is calculated at ( ) cm2." generates a measurement from aortic valve cross sectional area, not peak velocity.The potential impact of this incorrect measurement sentence is: incorrect aortic valve area method will be displayed in the sentence with a potential of under or over estimating the aortic valve area by peak velocity.Or the value may not be presented in a sentence, which creates the potential for misdiagnosis of disease status.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)(4).

• Brand Name: IMPAX CV OUTBOUND (RESULTS MANAGEMENT 2.08)
• Type of Device: PICTURE ARCHIVING AND COMMUNICATION
• Manufacturer (Section D): AGFA HEALTHCARE CORPORATION; 1 crosswind rd.; westerly RI 02891
• Manufacturer Contact: deborah huff ; 10 south academy street; greenville, SC 29601 ; 8644211754
• MDR Report Key: 4447403
• MDR Text Key: 15117066
• Report Number: 1225058-2014-00494
• 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: 10/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2014
• 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
• Date Manufacturer Received: 10/03/2014
• 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