Patients with diabetes who use insulin pens manufactured by Owen Mumford are being warned by the Medicines and Healthcare products Regulatory Agency to check if they have an affected LOT.
Owen Mumford has initiated a voluntary recall of affected LOTs and this is due to a dosage fault with the pens which could lead to hyperglycaemia if an underdose of insulin is given.
The fault with the four specific pens – Autopen Classic 1 unit pen, Autopen Classic 2 unit pen, Autopen 24 1 unit pen and Autopen 24 unit 2 pen – can cause the dose selector to suddenly revert to zero, potentially leading to people receiving an underdose of insulin or no insulin at all.
The failure rate of these 4,290 devices that have been distributed in the UK is 42%.
Dr Neil McGuire, MHRA clinical director of devices, said: “It is vital that people check if they have these affected pens and should obtain an alternative device before stopping using them.
He added that patients should seek a replacement at the earliest opportunity by contacting Owen Mumford via email@example.com.
To identify affected devices still within their packaging, patients and clinicians should look for the following packaging LOT code on the outer carton.
|Packaging lot code||Product code||Product name|
|7VJ||AN3810||3ml 1 Unit Autopen Classic|
|7WB||AN4200||Autopen 24 3ml 2 Unit|
|7WC||AN4210||Autopen 24 3ml 1 Unit|
|7WD||AN3800||3ml 2 Unit Autopen Classic|
|8CN||AN4200||Autopen 24 3ml 2 Unit|
|8CP||AN4200||Autopen 24 3ml 2 Unit|
|8CR||AN4210||Autopen 24 3ml 1 Unit|
|8EL||AN3800||3ml 2 Unit Autopen Classic|
|8EM||AN3810||3ml 1 Unit Autopen Classic|
|8JK||AN4210||Autopen 24 3ml 1 Unit|
|8JM||AN3800||3ml 2 Unit Autopen Classic|
|8JN||AN3810||3ml 1 Unit Autopen Classic|
|8JP||AN4210||Autopen 24 3ml 1 Unit|
|8VV||AN4200||Autopen 24 3ml 2 Unit|
|8VW||AN4200||Autopen 24 3ml 1 Unit|
To identify affected devices without packaging look for the following production LOT codes which can be found on the lower part of the pen body.
|Production lot code (stamped on pen)||Product code||Product name|
|7RT||AN3810||3ml 1 Unit Autopen Classic|
|7PN||AN4200||Autopen 24 3ml 2 Unit|
|7PP||AN4210||Autopen 24 3ml 1 Unit|
|7RV||AN3800||3ml 2 Unit Autopen Classic|
|8KK||AN3800||3ml 2 Unit Autopen Classic|
|8XD||AN4200||Autopen 24 3ml 2 Unit|