UK MDA warns about HumaPen problems

The Medical Devices Agency (MDA) in the UK has alerted the health service to an ongoing cartridge holder replacement programme for a brand of insulin injection pens. The manufacturer, Eli Lilly, is also running an advertising campaign to raise awareness of the replacement programme for the blue insulin cartridge holder in the HumaPen Ergo insulin injection pen. The blue cartridge holder needs to be replaced with a new redesigned clear cartridge holder.

Faults with the insulin cartridge holders for the HumaPen Ergo insulin injection pen may result in failure to deliver the correct dose of insulin. The failure is usually evident when the pen is primed before use and so users are normally aware that they may not have received the right amount of insulin. There have been no reports of serious adverse events, although some users have experienced problems.

An ongoing programme to replace the old cartridge holders has been conducted through community pharmacists, diabetes clinics and GPs since October 2000. However, recent research carried out on behalf of Eli Lilly has shown that an estimated 13% of HumaPen Ergo users – approximately 15,000 people – have not replaced the old design with the new one.