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

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 304 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 "there is diffuse global hypokinesis of the left ventricle" has been changed to: "there is mild to moderate global hypokinesis of the left ventricle." the original sentence indicates the presence of diffuse global hypokinesis of the lv, which means the entire lv is hypokinetic but the original sentence does not quantify the level of hypokinesis.Measurements such as ejection fraction etc.Would provide quantitative evidence of this level of functional impairment of the lv.The changed sentence however quantifies the hypokinesis of the lv as mild to moderate.Both sentences indicate that the hypokinesis is global.The prudent practitioner would key into the global hypokinesis content, as it is a red flag for hemodynamic stability, and look to the measurements of ef, sv, co if available to assess severity of disease.The changed sentence states that the hypokinesis is mild to moderate which may or may not be accurate.This could potentially lead to the overestimation or underestimation of level of disease.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)
• Type of Device: PICTURE ARCHIVING AND COMMUNICATION
• 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: 4660753
• MDR Text Key: 19814706
• Report Number: 1225058-2014-14347
• 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