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Medtronic Paradigm insulin infusion sets
Recall for product correction - Updating instructions for use
Consumers and health professionals are advised that Medtronic, in consultation with the TGA, has initiated a recall for product correction for its Medtronic Paradigm insulin infusion sets.
Insulin infusion sets are a tubing system used to deliver insulin from an insulin pump to the patient's body. Medtronic Paradigm insulin infusion sets are used with Medtronic Paradigm insulin pumps for the control of insulin-dependent diabetes.
A potential safety issue has been identified if insulin or other fluids come in contact with the inside of the Medtronic Paradigm insulin infusion set's connector, which connects the tubing system to the insulin reservoir. This is most likely to occur after the insulin reservoir is filled.
If this occurs, fluid can temporarily block the vents in the connector that allow the pump to prime before use. This can result in too much or too little insulin being delivered to the patient, which can cause hypoglycaemia or hyperglycaemia and require immediate medical attention. Medtronic has written to health professionals and Medtronic Paradigm insulin pump users, providing further information about this issue, including advice on how to prevent it from occurring.
The Instructions for Use for this device are being updated to address this issue.
The affected model numbers are:
Information for consumers
Please note that Medtronic Paradigm insulin infusion sets are not being recalled from the market.
Please check the model number of any Medtronic Paradigm insulin infusion sets to see if they are affected by this issue.
If you have any affected devices, you can continue to use them after noting the below information, which will advise you on how to prevent this issue from occurring.
Follow the below recommended reservoir filling procedure to prevent fluid from temporarily blocking the vents in the connector:
- After filling the insulin reservoir, make sure the vial of insulin is held upright when removing the reservoir from the blue transfer guard. This will prevent insulin from accidentally spilling on the top of the reservoir and potentially into the inside of the connector.
- Make sure the top of the insulin reservoir is dry before connecting it to the infusion set tubing. If any liquid is spilt on the top of the reservoir or inside the connector, do not use it – start over with a new reservoir and infusion set.
If you notice anything usual during the infusion set priming process, such as the insulin continuing to drip from the infusion set cannula after the manual prime has been completed, this may indicate that the vents in the connector may be blocked. If this occurs, do not attach the infusion set and call Medtronic’s 24-hour helpline on 1800 777 808 (option 1) for assistance.
If you have any questions or concerns about Medtronic Paradigm insulin infusion sets, contact the above helpline or contact your health professional.
Information for health professionals
Please note that Medtronic has written to Medtronic Paradigm insulin pump users, providing further information about this issue, including advice on how to prevent it from occurring (see 'Information for consumers').
If you have any questions or concerns about Medtronic Paradigm insulin infusion sets, contact Medtronic's 24-hour helpline on 1800 777 808 (option 1).
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.