0

We have encountered several situations where there is a deviation between the results generated when performing a search via Maude and the OpenFDA API. Below are two examples that we wish to get some consultation upon to clearly define why there is a deviation. 



Example 1. Adverse Events reported for a Product code. 



Results via API: Performing a query to the API in order to get all reported Adverse Events for the product code KQM during the dates 20230527 to 20240527 generates 11 hits / Adverse Events.
https://api.fda.gov/device/event.json?search=(device.device_report_product_code:KQM+AND+date_report:%5B20230527+TO+20240527%5D)&limit=20



Results from Maude: Adding KQM as Product Code and setting the time for Date Report Received to 05/27/23 to 05/27/24 generates 24 hits. 



We cannot see the logics in the deviation of the 13 additional hits generated via search on Maude vs API. enter image description here

Example 2. Adverse Events reported for a manufacturer.



Results via API: Performing a query to the API in order to get all reported Adverse Events for the manufacturer Barco NV during the dates 20230527 to 20240527 generates 5 hits / Adverse Events. 
https://api.fda.gov/device/event.json?search=((device.manufacturer_d_name.exact:(BARCO%20NV))+AND+date_received:%5B20230527+TO+20240527%5D)&limit=20



Results from Maude: Adding Barco NV as Manufacturer and setting the time for Date Report Received to 05/27/23 to 05/27/24 generates 20 hits. 



We cannot see the logics in the deviation of the 15 additional hits generated via search on Maude vs API. The deviation remains no matter we use date_received or date_report. enter image description here

We kindly ask for advisory on this matter since an auditor most likely would use Maude and we rely on the API… compliance matters.

3
  • Thank you for reporting this, Marcus, we are looking into it. Commented May 31 at 19:17
  • Just to give you an update. openFDA builds its Device Recalls dataset from the MDR Data Files located here: fda.gov/medical-devices/…. Unfortunately, it appears FDA posted a broken device.zip on that page, which managed to slip into openFDA as well. We are working with CDRH to get that fixed. stay tuned. Commented Jun 3 at 14:05
  • Thx Denis, I appreciate that!
    – Marcus
    Commented Jun 7 at 7:59

1 Answer 1

0

This has been fixed. Please do let us know in case you run into issues. Thank you.

Your Answer

By clicking “Post Your Answer”, you agree to our terms of service and acknowledge you have read our privacy policy.

Not the answer you're looking for? Browse other questions tagged or ask your own question.