12 Other Considerations

For submitting a Malfunction Only (No AE) report to CBER, these are the data entry recommendations:

1. Patient tab:
   • No data required to be entered in the Patient Information, Patient Details, Race Information, Other Relevant History sections. Export mappings populates most of the Patient elements as None, as per regulations.
   • Click on the Patient Notes icon in the Patient Information section, either enter the text None in the text area or select any Null flavor using the NF button.
2. Product Tab: Set the Malfunction field to Yes and select one or more Device Problem codes in the Device tab of the Constituent Device Product.
3. Event tab:
   • Enter No Adverse Event as Reported term to get the properly coded corresponding MedDRA term.
   • Set Null Flavor NASK for the following fields:
     • Onset date/time
     • Stop date/time
   • Outcome of Event: Unknown
4. Analysis tab:
   • Case Serious is set to No.