Certain batches of insulin pens manufactured by Novo Nordisk have been recalled as the cartridge holders may not be strong enough to withstand some household cleaners.
The Medicines and Healthcare products Regulatory Agency (MHRA) have issued a medical device alert to notify hospitals and users to return affected batches to Novo Nordisk for replacement.
NovoPen Echo and NovoPen 5 are both affected by the recall. A total of 87 batches in the U.K. have been recalled by way of a field safety notice, citing broken or cracked cartridges as the problem.
About the issue
It seems the life-saving devices may become defective when exposed to certain household chemicals, including “cleaning agents, sunscreen and food grease.” With with the non-corrosive nature of sunscreen and food grease, the cartridge cracking is said to be “extremely unlikely”, however.
Novo Nordisk blames the type of plastic used for the newer cartridge holders and reverted back to using the original materials where there were no reports of cracking or breaking previously made.
The dangers of the defect
The danger of the defect lies in the potential for a disrupted amount of product delivered to the patient. Diabetic people use insulin pens to control their blood sugar levels, so if the cartridge holder is exposed to certain substances, it can crack or break causing the insulin to leak out or restrict the amount of insulin administered.
With high blood sugar levels, the lack of adequate insulin could put a diabetic person at risk of hyperglycaemia.
Scarily with hyperglycaemia, the patient may not even experience any physical signs of high blood pressure and may not know their blood sugar levels are dangerously high.
Accordingly to the NHS, symptoms of hyperglycaemia can include:
- Increased thirstiness
- Dry skin
- Needing to urinate a lot
- Tiredness
- Fruity (acetone) breath
- Blurred vision
- Weight loss and loss of appetite
- Infections
- Nausea
Extreme hyperglycaemia can have life threatening complications, such as:
- Diabetic Ketoacidosis – a type of diabetic coma
- Hypersmolar hyperglycaemic state – severe dehydration
Warnings to patients
Whilst users are requested to bring in the recalled devices, diabetes sufferers are being asked to not stop treatment without consulting a doctor. Users are encouraged to keep checking their blood sugar levels, especially after using any insulin treatment.
Novo Nordisk have provided their contact details and extended opening hours of their care lines in efforts to ensure users can reach them for advice and help. The company has apologised for the recall and emphasises that “the safety of patients is of utmost importance for Novo Nordisk.”
Image Credit: https://www.sec.gov/Archives/edgar/data/353278/000120864613000045/c107893.htm
First published by Admin on November 06, 2017
Posted in the following categories: Medical Recalls and tagged with recalls