Certain Batches ‘Could Pose Risk To Patients’
Medical device manufacturer has launched a recall of specific batches of its Autopen Classic, Autopen 24, Densupen and Autopen 3ml for Teriparatide insulin pens.
The company has confirmed it is taking the step as a result of a potential mechanical fault in relation to the products, which would see a dose dialled up with the dose selector not holding the dose and spinning back to zero.
In addition, the fault may also emerge when a dose is dialled up and the selector holds it momentarily, before then spinning back to zero.
According to the company, this could lead to the patient not being able to use the pen as no dose may be delivered. Alternatively, the patient may receive a partial dose and will not know much insulin has been provided.
Wholesalers, distributors and pharmacists have been asked to check batch numbers and place any affected under quarantine. A full list of the relevant batches is available on the Owen Mumford website.
Expert Opinion
Many people with diabetes rely on insulin pens to ensure that they receive the correct level of insulin at the right time, so the concerns raised in relation to these batches is a major concern which could have major consequences for patients. <br/> <br/>"It is vital that wholesalers, distributors and pharmacists take action to ensure the public are protected from potential risks, while the manufacturer must also take steps to understand how products with this fault made it to market. <br/> <br/>"Many people suffer injury or illness as a result of defective medical products every year and it is vital that everything is done to ensure that safety always comes first."