Temperature excursion information
Who is contacting us?
A temperature excursion or breach is defined as storage or exposure of a Roche product outside the labelled storage temperatures for any length of time.
Are you a…
Temperature Excursion Details
Definition:
A temperature excursion or breach is defined as storage or exposure of a Roche product outside the labelled storage temperatures for any length of time.
Please provide details of the temperature excursion but do not provide any personal data (including sensitive personal data). To enable an accurate assessment, it is important that the time and temperature data you have provided are both complete and accurate. You will be able to add the affected products on the next page.
Specify recorded temperature(s) excursion (one value is mandatory)*
Duration below lower limit
Duration above upper limit
How many times did the temperature drop below 0.5ºC and came back up to 0.5ºC?
Any other details?
Attach your fridge log sheet (optional)
Product Information
Additional products? ({{form.products[index].index}})
Please provide information on the affected products. You can add multiple products (per Batch/Lot Number) by using the “Add Product” button at bottom of this page.
Which product is affected in the reported excursion?
Do you have a patient waiting for the product?
Has the product been involved in a previous temperature excursion while in your possession?
Has the product been reconstituted/diluted?
Is the product at its final storage location before being administered /dispensed /supplied to the patient?
Has the product been administered to the patient?
Products affected by the reported excursion
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Contact Details
Please complete the form by adding your contact details
I consent to my data being processed for the purpose of responding to my inquiry and in accordance with the Roche Privacy Policy,
By clicking on the 'Submit' button below, you consent to Roche Products Pty Ltd ("Roche") collecting, storing, using and disclosing your personal information ("Data") in order to respond to your inquiry, fulfil your request for information relating to Roche products; fulfil our regulatory or legal obligations; and monitor the safety and efficacy of our products. If you do not consent to the Data processing, we may be unable to respond to your message or fulfil your request for information, and kindly ask that you use other channels to contact us.
Your Data may be stored on, accessed or processed by and shared with other affiliates within the global Roche Group, third-parties working with Roche or Roche affiliates located both within and outside of Australia, regulatory authorities or as required by law.
By including personal information of another data subject in the form, you represent the lawfulness of processing of such personal information.
Roche Privacy Policy includes important information about how Roche collects, uses and discloses your Data, how you can access or seek correction of your Data, how you can complain about a breach of the Privacy Act 1988 (Cth) and how we will deal with a complaint of that nature.
Your report
Which Roche product has been affected? Please provide as much information as possible about the product and event but do not provide any personal data (including sensitive personal data). This information will be sent to the local Roche office who may contact you for further information. You will receive a notification once your case has been assessed. Please ensure that product is correctly stored while waiting to hear back from us.
Product name
Additional Product Details
What happened to the product?
Contact Details
Please complete the form by adding your contact details
I consent to my data being processed for the purpose of responding to my inquiry and in accordance with the Roche Privacy Policy,
By clicking on the 'Submit' button below, you consent to Roche Products Pty Ltd ("Roche") collecting, storing, using and disclosing your personal information ("Data") in order to respond to your inquiry, fulfil your request for information relating to Roche products; fulfil our regulatory or legal obligations; and monitor the safety and efficacy of our products. If you do not consent to the Data processing, we may be unable to respond to your message or fulfil your request for information, and kindly ask that you use other channels to contact us.
Your Data may be stored on, accessed or processed by and shared with other affiliates within the global Roche Group, third-parties working with Roche or Roche affiliates located both within and outside of Australia, regulatory authorities or as required by law.
By including personal information of another data subject in the form, you represent the lawfulness of processing of such personal information.
Roche Privacy Policy includes important information about how Roche collects, uses and discloses your Data, how you can access or seek correction of your Data, how you can complain about a breach of the Privacy Act 1988 (Cth) and how we will deal with a complaint of that nature.