IMPAX CV REPORTING

Description of Event or Problem

ON (B)(6) 2013, A LEAD ECHO SONOGRAPHER ALERTED AGFA THAT ULTRASOUND MEASUREMENTS WERE INSERTED IN THE WRONG LOCATION FOR 2 DIFFERENT PHILIPS IE-33 ULTRASOUND CARTS. THE CARDIOLOGIST WAS CONCERNED THAT ERRONEOUS MEASUREMENTS RESULTED IN INCORRECT DIAGNOSIS AS THE MITRAL REGURGITATION IS RATED HIGHER THAN IT ACTUALLY IS. ADDITIONALLY, THE SPECIFIC MEASUREMENT VALUES WERE NOT CONSISTENT WITH THE ACQUIRED IMAGE STUDIES. AGFA'S INVESTIGATION OF THIS MDR REVEALED THAT IN 2012 A CORRECTION WAS IMPLEMENTED BY AN AGFA CLINICAL ANALYST BY RECONFIGURING THE CUSTOMER'S SYSTEM TO ELIMINATE THE TYPE OF MISMAPPING SEEN IN THIS CURRENT MDR (THE 2012 EVENT AND CORRECTION WERE REPORTED VIA FDA MDR 1225058-2012-00002). THIS PAST CORRECTION WAS MISTAKENLY REVERTED TO ITS PREVIOUS CONFIGURATION IN IMPAX CV FOR PHILIPS IE-33 ULTRASOUND CARTS BY AN AGFA PROFESSIONAL SERVICES PERSON, THUS RE-ENABLING THE ERRORS INITIALLY FOUND ON (B)(6) 2012. ON (B)(4) 2013, AGFA CORRECTED THE ISSUE BY RECONFIGURING THE CUSTOMER'S SYSTEM AND ELIMINATING THE MISMAPPING. THE CUSTOMER HAS CONFIRMED THE IMPLEMENTED CORRECTION HAS FIXED THE PROBLEM AND THERE ARE NO FURTHER ISSUES. NO REPORTS OF PT HARM WERE REPORTED DURING THIS EVENT.

Additional Manufacturer Narrative

THE CUSTOMER'S SOFTWARE VERSION USED IS: VERSION: 2.04.67.00.SU2, RELEASE DATE: 02/06/2010 (ALSO CALLED CV 7.4 SU3). EVALUATION SUMMARY: AGFA'S INVESTIGATION OF THIS MDR REVEALED THAT IN 2012 A CORRECTION WAS IMPLEMENTED BY AN AGFA CLINICAL ANALYST BY RECONFIGURING THE CUSTOMER'S SYSTEM TO ELIMINATE THE TYPE OF MISMAPPING SEEN IN THIS CURRENT MDR (THE 2012 EVENT AND CORRECTION WERE REPORTED VIA FDA MDR 1225058-2012-00002). THIS PAST CORRECTION WAS MISTAKENLY REVERTED TO ITS PREVIOUS CONFIGURATION IN IMPAX CV FOR PHILIPS IE-33 ULTRASOUND CARTS BY AN AGFA PROFESSIONAL SERVICE PERSON, THUS RE-ENABLING THE ERRORS INITIALLY FOUND ON (B)(6) 2012. ON (B)(4) 2013, AGFA CORRECTED THE ISSUE BY RECONFIGURING THE CUSTOMER'S SYSTEM AND ELIMINATING THE MISMAPPING. THE CUSTOMER HAS CONFIRMED THE IMPLEMENTED CORRECTION HAS FIXED THE PROBLEM AND THERE ARE NO FURTHER ISSUES. NO REPORTS OF PT HARM WERE REPORTED DURING THIS EVENT. DURING THE INVESTIGATION IT WAS DISCOVERED 185 STUDY DATES WERE IMPACTED AND INCLUDED 1415 MRNS (MEDICAL RECORD NUMBERS). AGFA WILL SUBMIT A MDR TO THE FDA FOR EACH OF THE 185 STUDY DATES AND INCLUDE SPECIFIC MRNS REFERENCING EACH STUDY DATE. THE MDR SUBMISSION NAMES FOR THE ENTIRE EVENT WILL INCLUDE: 1225058-2013-00001 THROUGH 1225058-2013-00185. STUDY DATE: (B)(6) 2011. MRNS: (B)(6).