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Consumers and health professionals are advised that Merck Serono Australia, in consultation with the TGA, is recalling the 5.1 model of Easypod auto injectors and replacing it with a newer model.
Easypod auto injectors are medical devices that can be used to administer Saizen (somatropin), a human growth hormone used to treat growth failure in children and growth hormone deficiency in adults. The auto injector is pre-programmed to deliver the correct dose of Saizen to the user. However, not every patient being treated with Saizen uses an Easypod auto injector.
It has been identified that there is potential for patients using the current 5.1 model to inject too much or too little Saizen if they override a safety mechanism that warns if the Saizen cartridge does not match the device's programmed settings.
Merck Serono Australia is arranging to replace all of these devices (and any earlier models) with the new 5.2 model free of charge. The new model will not give an injection if the information programmed into the device does not match the information about the Saizen loaded into it.
Information for consumers
If you are being treated with Saizen you will be contacted by either your doctor, pharmacist or Merck Serono Australia (depending on if your medicine is subsidised under the Pharmaceutical Benefits Scheme or obtained on private prescription).
If you use an Easypod auto injector, you will be provided further information about this issue and instructions for getting your replacement device. The new device will be supplied through your local pharmacy.
Do not stop using Saizen. Continue treatment as directed by your doctor while you wait for your replacement device.
If you have any questions or concerns about this issue, please contact Merck Serono Australia on 1800 685 536.
Information for health professionals
Merck Serono Australia has written to doctors who have prescribed Saizen to patients to provide further information about this issue. Those doctors have been asked to contact those patients to verify if they use Easypod auto injector and, if so, to provide them a patient information leaflet.
Affected patients should be advised to continue using Saizen while waiting for their replacement device.
The potential for incorrect dosing was identified after investigation of overseas reports, in which inadequate reprogramming of Easypod auto injectors had been undertaken when patients switched from Saizen solution to Saizen powder. Saizen solution is available in either 5.83 mg/mL or 8 mg/mL concentration, but the powder is only available in 5.83 mg/mL concentration. While the 5.1 model has a safety mechanism that warns the patient to check the Saizen cartridge when it is not recognised by the device, that feature can be overridden if the patient removes the label from the cartridge and forces the device to proceed to injection.
The 5.2 model of Easypod auto injectors will not proceed to injection if the cartridge in the device does not match the programmed settings. Further, this feature cannot be overridden by the patient.
If you have any questions or concerns about this issue, please contact Merck Serono Australia on 1800 685 536.
Information for pharmacists
Merck Serono Australia is writing to pharmacists who have supplied Easypod auto injectors to patients, providing further information about this issue and the recall procedures.
The recall procedure requires affected patients to nominate a pharmacy to which their replacement device will be sent for collection. As a result, you may be contacted to assist in ensuring patients receive their new Easypod auto injector.
If you have any questions or concerns about this issue, please contact Merck Serono Australia on 1800 685 536.
Reporting problems
Consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to the TGA's monitoring of these products. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS).
The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.