Subject: SAE Notification - Performance Study 2023-504753-12-00
From: "Sobczak, Rachael" <[email-masked]>
To: <[email-masked]>
Cc: "Lydia Gateri" <[email-masked]>, "Mahsa Ghaffari" <[email-masked]>, "Veronica Andaya" <[email-masked]>, "Adama Parham" <[email-masked]>
Date: Wed, 11 Jun 2025 01:02:54 +0300

Tähelepanu! Tegemist on väljastpoolt asutust saabunud kirjaga. Tundmatu 
saatja korral palume linke ja faile mitte avada.

Dear Sir/Madam,

Please find attached an IVD SAE Report form (IVDR Performance Study Summary 
Safety Reporting Form MDCG 2024-4 Appendix) for the IVD Performance 
Evaluation with PSP code RD006691.

The SAE is related to a study procedure (sample collection) occurring 
outside Estonia, and does not directly involve patients in Estonia. Testing 
with the IVD device occurred in Edinburgh, Scotland. The event is reported 
as the study procedures and testing are conducted under the same IVD 
protocol that will be used for Estonian patients. The device manufacturer 
causality assessment has found that the SAE was not related to the device.

Please advise if any additional information is required.

Kind regards,

Rachael Sobczak

Global Studies Leader

IQVIA Agent representing Roche Diagnostic Solutions

Mobile: 317-965-7205

Email:  <mailto:[email-masked]> 
[email-masked]

Upcoming OOO: N/A