NordiPen used with 5 mg, 10 mg and 15 mg Norditropin SimpleXx cartridges
Recall for product correction - potential for under-dosing due to assembling difficulties
Consumers and health professionals are advised that Novo Nordisk Pharmaceuticals, in consultation with the TGA, has initiated a recall for product correction of certain lots of its NordiPen medical device.
NordiPen is a non-sterile, re-usable injector pen. NordiPen is used with 5 mg, 10 mg and 15 mg Norditropin SimpleXx (somatropin) cartridges. Norditropin SimpleXx is human growth hormone used to treat growth failure in children and growth hormone deficiency in adults. NordiPen can also be used in conjunction with NordiPenMate.
It has been identified that some users may have difficulty assembling their NordiPen. An investigation has revealed that a minor design change to the shape of a component of NordiPen could lead to increased resistance during assembly. This could cause the user to assume that the pen is correctly assembled when it is not, which may lead to the patient injecting less medicine than the intended dose.
NordiPen with lot numbers beginning with an A, B or C may be affected (see 'Information for consumers' for instructions on how to find the lot number). Please note that not all users with devices from these lots will experience problems and correctly assembled devices will perform as intended.
In response to this issue, Novo Nordisk Pharmaceuticals is undertaking design improvements for NordiPens and will replace all affected devices once unaffected stock is available. Unaffected stock is expected to be available in October 2013.
Additionally, Novo Nordisk Pharmaceuticals is updating the NordiPen's instruction manual and, in the meantime, is providing clarified assembly instructions for health professionals and NordiPen users.
Please note that this issue is strictly device related. There are no concerns regarding Norditropin SimpleXx cartridges.
Information for consumers
Please note that NordiPen is not being recalled from the market.
Novo Nordisk Pharmaceuticals is writing to health professionals who have been supplied with NordiPen from affected lots to provide further information about this issue, including clarified assembly instructions. Those health professionals are being asked to pass on this information to patients supplied with NordiPen from affected lots.
If you have a NordiPen, check the device's lot number to see if it is affected by this issue (if its lot number begins with an A, B or C). The lot number is located on the mechanical section below the push button and can be exposed by turning the dose selector clockwise.
If you have a NordiPen from an affected lot, contact the health professional from whom you received your device to get the updated assembly instructions for the device.
The updated instructions clarify that, with the starting position shown in the picture below, it takes three complete turns (three times 360°) to screw the two parts of the NordiPen together correctly.
If a slight resistance is felt in the first turn, keep turning until three complete turns are made.
If a strong resistance is felt before three complete turns are made, the screw threads within the cartridge holder might be misaligned. If this happens, unscrew the two parts of the NordiPen and start over, ensuring the screw threads are correctly aligned.
The two parts of the NordiPen are correctly assembled when:
- three turns are made
- the strength indicator on the cartridge holder and the mg pointer on the mechanical section are aligned, and the distance between the edge of the cartridge holder and the raised dose indicator window is about 1 mm (see picture below).
Please note that, if you are also using a NordiPenMate, it takes four complete turns to correctly assemble the device. The blue insertion button on the NordiPenMate and the mg pointer on the mechanical section of the NordiPen should be aligned, and the distance between the edge of the NordiPenMate and the raised dose indicator window of the NordiPen should be about 3 mm (see picture below).
If you have any questions or concerns regarding this issue phone NordiCare Customer Care Centre on 1800 632 362, or contact the health professional from whom you received your device.
Information for all health professionals
Novo Nordisk Pharmaceuticals is writing to health professionals who have been supplied with NordiPen from affected lots to provide further information about this issue. Included in this information are two updated instruction documents intended for users - 'Additional information regarding assembly of NordiPen 5 mg, NordiPen 10 mg and NordiPen 15 mg' and 'Additional information regarding assembly of NordiPen 5 mg, NordiPen 10 mg and NordiPen 15 mg when using NordiPenMate'.
If you are treating patients who use NordiPen, please ensure they are aware of this issue and provide them the relevant updated instruction documents.
If you have any questions or concerns about this issue, phone NordiCare Customer Care Centre on 1800 632 362.
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.