Imagine having an allergic reaction and the medication to save your life cannot be dispensed. SYMJEPI is an emergency treatment for patients who have an allergic reaction to something or anaphylaxis to stinging insects, allergen immunotherapy, foods, drugs, diagnostic testing substances and more. This injection is an emergency Epinephrine medication that is injected into patient when reaction is occurring.
SYMJEPI was recalled due to potential clogging in the syringe needle. This prevented epinephrine being distributed into a patient. Incidents like this could lead to death.
Four lots of SYMJEPI were recalled.
How did multiple syringe needles have malfunctions? Was testing done properly? What did the clean room look like?
With InQuest Science’s Identifier Software, we track and trace, ensure and guide all data that is entered. Requirements are set within the software, and any alterations following is traced. This tactic will lead to less falsified data, identifying products with defects and reminding when products and inspectors should be tested again.
When products are held to a standard, that standard should be defined and never altered. In paper-based systems, data integrity is always at risk and it is unknown if humans record the data information correctly. Our software will lock down information, require management to double check work and help push manufactures into testing all products correctly.