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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.
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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}})
If the product is not yet administered for patient, please advice the patient not to use the product.
Please provide information on the affected products. You can add multiple products by using the “Add Product” button at bottom of this page.
Which products were 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 & Privacy Notice for Pharmacovigilance.
You consent, by ticking the box above, to the processing of your data for the purposes of responding to your inquiry and in accordance with the Roche Privacy Notice for Pharmacovigilance, medical information and product complaints. If you do not consent to the data processing, we will not be able to reply to your message and kindly ask you to use other channels to contact us.
Roche (Philippines) Inc. ("Roche") is required by law to record and/or report adverse events. Therefore, your data will be processed for these purposes in accordance with the specific GVP (pharmacovigilance) legislation, as further described in the Roche Privacy Notice for Pharmacovigilance, Medical Information and Product Complaints.
Roche will retain the personal information you provide for the purposes of responding to your request, following up on such requests, retaining the information in Roche's global pharmacovigilance database for reference purposes and to comply with our legal and regulatory record-keeping and reporting obligations. The retention period of the data is in accordance with the relevant laws and regulations.
By including personal data of another data subject in the form, you declare the lawfulness of the processing of this personal data.
The Privacy Policy provides more detailed information about your rights and how Roche processes personal data.
Your report
If the product is not yet administered for patient, please advice the patient not to use the product.
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 & Privacy Notice for Pharmacovigilance.
You consent, by ticking the box above, to the processing of your data for the purposes of responding to your inquiry and in accordance with the Roche Privacy Notice for Pharmacovigilance, medical information and product complaints. If you do not consent to the data processing, we will not be able to reply to your message and kindly ask you to use other channels to contact us.
Roche (Philippines) Inc. ("Roche") is required by law to record and/or report adverse events. Therefore, your data will be processed for these purposes in accordance with the specific GVP (pharmacovigilance) legislation, as further described in the Roche Privacy Notice for Pharmacovigilance, Medical Information and Product Complaints.
Roche will retain the personal information you provide for the purposes of responding to your request, following up on such requests, retaining the information in Roche's global pharmacovigilance database for reference purposes and to comply with our legal and regulatory record-keeping and reporting obligations. The retention period of the data is in accordance with the relevant laws and regulations.
By including personal data of another data subject in the form, you declare the lawfulness of the processing of this personal data.
The Privacy Policy provides more detailed information about your rights and how Roche processes personal data.