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