8 Similar Device Case Processing (Single Entity Combination Products)

The following stept are required to create and process cases that have a Non-US marketed device which involves reportable malfunction with similar devices that are marketed in the US. These devices are part of Single entity Combination Product.

  1. Book-in a Case with information received as per Source documents.
  2. If the Suspect Device had caused a reportable malfunction, then check for the Product Portfolio for Similar devices marketed in US as Combination Product.
  3. If a US Marketed similar device product, that is part of Single entity combination product already exists, add the Product from the Product browser and enter the following data in the Vaccine tab:
    1. Product type = Treatment
    2. Drug not administered =Ticked
  4. Enter the following data in the Device tab:
    1. Similar Device= Ticked
    2. Malfunction = Yes
    3. Specify the Device problem information by selecting appropriate FDA/IMDRF Codes using the lookup.
  5. Select Combination Product in the General Tab > Case Classification field.
  6. Save the case and ensure all the mandatory data is entered that is required for CBER submission.
  7. Perform Auto-scheduling and system schedules for an eVAERS report for the suspected vaccine which caused malfunction to the CBER agency.
  8. Click the Draft link to preview the report in XML view:
    1. The element <fulfillexpeditedcriteria> is populated with value false indicating Non-expedited report.
    2. The element <localcriteriareporttype> is populated with the value 5 indicating ICSR is a Malfunction.
    3. The element <drugcharacterization> is populated with value 4 indicating that the drug was not administered.
    4. The element <otherdrugcharacterization> is populated with value 1 indicating Similar Device.
  9. The Similar Device data is populated in the XML view of ICSR viewer as shown in the example below.
<drug>                       
          <drugcharacterization>4</drugcharacterization>                        
          <otherdrugcharacterization>1</otherdrugcharacterization>                       
          <medicinalproduct>BCG-Vaccine</medicinalproduct>
       <deviceinfo>       
          <malfunction>true</malfunction>                       
          <brandname>BCG-Vaccine Needle</brandname>                       
          <commondevicename>Needle</commondevicename>   
       </deviceinfo>
</drug>