BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPAX CV 7.8 SU3

    MDR report key: 3622756 · Received February 11, 2014

    Report

    Report Number
    1225058-2014-00013
    Event Type
    Malfunction
    Date Received
    February 11, 2014
    Date of Event
    December 17, 2013
    Report Date
    February 7, 2014
    Manufacturer
    AGFA HEALTHCARE CORP.
    Product Code
    LLZ
    PMA / PMN Number
    K050228
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS MDR IS BEING REPORTED ON (B)(4) 2014. AGFA HAS DETERMINED THAT THE AWARENESS DATE OF THIS EVENT WAS ACTUALLY (B)(4) 2013, AS AGFA WAS AWARE OF THE ISSUE ON THIS DATE, BUT FAILED TO REPORT THE ISSUE TO ESCALATE THE EVENT FOR INVESTIGATION; ALTHOUGH TROUBLESHOOTING ACTIVITIES WERE ONGOING DURING THE (B)(6) 2013 AND (B)(6) 2014 TIMEFRAME TO IDENTIFY THE PROBLEM RELATED TO THIS EVENT. ON (B)(6) 2014, THE SITE REPORTED THAT WEIGHT WAS BEING MISAPPROPRIATED TO THE HEIGHT FIELD, AND THE WEIGHT FIELD WAS BLANK, ON ALL PEDIATRIC OCR STUDIES. AS PART OF AN UPGRADE TO THE SITE¿S PEDIATRIC OCR REPORTING, AGFA SOLUTIONS DEPLOYMENT SPECIALIST AND ZONE SUPPORT SPECIALIST/PROFESSIONAL SERVICES BOTH CONFIRMED THAT THE HOT FIX OCR SERVICE.7.8.SU3.HF.20130607 HAD BEEN APPLIED TO THE PRODUCTION SYSTEM DURING THE UPGRADE AND PRIOR TO THE SITE¿S ¿GO LIVE¿ ON (B)(6) 2013. THE HOT FIX INCLUDED IN THE MANDATORY SERVICE WITHIN THE UPGRADE WAS THE CORRECTION TO PREVENT THIS TYPE OF ISSUE THE SITE REPORTED ON (B)(6) 2014. ON (B)(6) 2014, AGFA INVESTIGATION IMMEDIATELY DETERMINED THAT ONCE THE UPGRADE WAS COMPLETED AND THE HOTFIX APPLIED ON (B)(6) 2013, THE AGFA SPECIALISTS DID NOT EXECUTE THE VERIFICATION PORTION OF THE MANDATORY SERVICE ASSOCIATED WITH THE HOTFIX. ON (B)(6) 2014, THE SAME DAY THE CUSTOMER REPORTED TO AGFA, AGFA MADE THE CORRECTION TO THE SITE¿S PEDIATRIC OCR REPORTING. THE HOT FIX OCR SERVICE.7.8.SU3.HF.20130607 WAS SUCCESSFULLY APPLIED REMOTELY BY AGFA REGIONAL SUPPORT SPECIALIST. THE CUSTOMER TESTED THE PEDIATRIC OCR REPORTING AFTER THE HOTFIX WAS SUCCESSFULLY APPLIED. THE HEIGHT AND WEIGHT FIELDS SHOWED IN THE CORRECT FIELDS. AGFA CONFIRMED THE HOTFIX IS PERFORMING AS DESIGNED AND WAS NOT THE ISSUE OF THE FAILURE REPORTED BY THE SITE ON (B)(6) 2014. THEREFORE, THE ROOT CAUSES OF THE EVENT ARE THE HOTFIX HAD NOT BEEN APPLIED CORRECTLY AND NO VERIFICATION PER THE MANDATORY SERVICE WAS PERFORMED AT THE TIME OF THE UPGRADE. THIS LED TO THE WEIGHT BEING MISAPPROPRIATED TO THE HEIGHT FIELD, AND THE WEIGHT FIELD BEING BLANK IN THE PEDIATRIC OCR REPORTING. DURING THE INVESTIGATION IT WAS DISCOVERED 27 STUDY DATES WERE IMPACTED AND INCLUDED 358 MRNS (MEDICAL RECORD NUMBERS). AGFA WILL SUBMIT A MDR TO THE FDA FOR EACH OF THE 27 STUDY DATES AND INCLUDE THE SPECIFIC MRN/S REFERENCING EACH STUDY DATE. THERE IS NO REPORT OF PATIENT HARM DUE TO THIS EVENT. BELOW ARE THE MDR#S , MRNS AND STUDY DATES FOR THESE EVENTS. FOR THIS MDR, THE FOLLOWING ARE THE MEDICAL RECORD NUMBERS AND STUDY DATE: MRN STUDY DATE (B)(6), (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90894 IMPAX CV 7.8 SU3 IMPAX CV 7.8 SU3 - OCR SERVICE LLZ AGFA HEALTHCARE CORP. IMPAX CV 7.8 SU3 HF.20130607 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1