A Medical Device Alert (MDA/2009/019) has been issued for the following lots of Owen Mumford Autopen® Classic (1 unit 3ml) insulin pens, which have been supplied in the UK since February 2008:

• Product code: AN3810
• Affected lots: CJF, DBR, DEX, DMP, DND BRG and CCW

Owen Mumford has informed the MHRA of a manufacturing failure in the affected lots of these devices, which prevents the plunger of the pen advancing, resulting in no insulin being dispensed. The dose knob will, however, still click and return to zero, so the patient may think that a dose has been delivered.  There if therefore a risk of underdosing of insulin leading to hyperglycaemia.  The Autopen Classic (1 unit 3ml) devices are specifically for use with Eli Lilly and Wockhardt UK insulin cartridges.

The following advice has been issued for pharmacists supplying these devices or Eli Lilly/Wockhardt UK insulin:

• Do not supply affected devices.
• Quarantine affected devices from your current stock and contact Owen Mumford Ltd for replacements (tel: 01993 812021).
• If a patient returns an Autopen Classic 1 unit device, first check the device to confirm whether it is from one of the affected lots. If it is, supply the patient with a new device and contact Owen Mumford Ltd for replacement stock.
• When you dispense Eli Lilly or Wockhardt UK insulin, advise users of affected product to seek a replacement pen, and to prime the device prior to each injection (see appendix 2, patient information leaflet).

The full alert can be viewed at the links below.