Adverse Event and Product Complaint Reporting
Part of Freedom For All Diagnostics™, Inc.’s mission to serve patients includes collecting, reviewing, and reporting all adverse events, other safety findings, and product complaint information associated with the use of Freedom For All Diagnostics™, Inc.’s investigational and marketed products.
It is Freedom For All Diagnostics™, Inc.’s policy to comply with all regulations and laws worldwide relating to reporting adverse events, other safety finding and product complaints. Individuals subject to this policy are required to report adverse events, other safety findings, and product complaints within one business day.
Adverse Events (AE)
An AE is any untoward medical occurrence in a patient administered a Freedom For All Diagnostics™, Inc. product, and which is not necessarily caused by the Freedom For All Diagnostics™, Inc. product. An AE can, therefore, be any unfavorable and unintended sign (e.g., an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, combination product, or medical device, whether or not considered related to the product. This includes:
- Any clinically significant worsening of a pre-existing condition; or
- An AE that has been associated with the discontinuation of the use of a product.
Other Safety Findings
The following are considered Other Safety Findings regardless of whether they are associated with an AE and they must be reported to Freedom For All Diagnostics™, Inc.:
- Use of a Freedom For All Diagnostics™, Inc. product while pregnant and/or breastfeeding. This includes pregnancies in women whose sexual partner took, or is taking, a Freedom For All Diagnostics™, Inc. product.
- Medication errors
- Transmission of an infectious agent through a contaminated Freedom For All Diagnostics™, Inc. product
- Accidental Exposure
- Occupational Exposure
- Lack or loss of therapeutic efficacy
- Missed dose, if not taken prior to the next scheduled
- Reports of patient “death” after exposure to Freedom For All Diagnostics™, Inc. product where no other details are provided (e.g., fatal outcomes)
- Off-label use of a Freedom For All Diagnostics™, Inc. product defined as the intentional use of a product in a manner inconsistent with the locally approved label, i.e., a different dose, use, indication or patient population than that approved in the local label. U.S. Commercial field staff are not required to report off-label use unless the off-label use is associated with an AE. However, US Commercial field staff must report all other AEs, PCs, and OSFs irrespective of whether the event is from on-label or off- label use.
Product Complaints (PC)
Any written, electronic or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a drug, combination product, or device after it is released for distribution to market or clinic by either: (1) Freedom For All Diagnostics™, Inc. or (2) distributors or partners for whom Freedom For All Diagnostics™, Inc. manufactures the material. This includes all components distributed with the drug, such as packaging, drug containers, delivery system, labeling, and inserts. Examples include:
- A device that is damaged or broken
- Bent or blunt needles
- Missing or illegible labeling
- The inability of the customer to administer the product
- Product with an unexpected color, appearance, or particles
- User error (i.e, an act or omission of an act that results in a different combination product or medical device response than intended by the manufacturer or expected by the user, where the user attempted to use the combination product or medical device in good faith and experienced difficulty or deficiency administering the product)
Reports of misuse of a combination product or medical device (i.e, the intentional and improper use of a combination product or medical device not in accordance with the authorized product information) are not considered Product Complaints.
What to Report
When reporting an AE, other safety finding or product complaint, you will need at to have the following information ready:
- The identifiable patient:
- The person who has taken or been administered the product (e.g. age, gender, etc.), in compliance with local privacy laws.
- An identifiable reporter:
- The source that reported the event (e.g. patient, health care provider, friend, etc.), in compliance with local privacy laws.
- The medicinal product:
- Freedom For All Diagnostics™, Inc. product name, indication, and lot number if known.
- The reportable event:
- Description of the AE, other safety findings, or product complaints.
You should still report AE, other safety findings, and product complaints even if you do not have all the required information. Please report as much relevant information as possible.
It does not matter whether the reportable event is thought to be caused or not thought to be caused by taking a Freedom For All Diagnostics™, Inc. product – all AEs, other safety findings, and product complaints must be reported. Report a reportable event even though it is listed in the approved company prescribing information as a possible side effect. When in doubt, report it.
How to Report
All information that pertains to an AE, other safety findings, or product complaint must be directed to Freedom For All Diagnostics™, Inc. for review and analysis as appropriate. Report adverse events, other safety findings, and product complaints related to any Freedom For All Diagnostics™, Inc. product to Freedom For All Diagnostics™, Inc. by calling: