The Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom, has issued a medical device safety alert concerning Cellnovo Insulin Infusion System – Bolus Dose Calculator [Part Number: 7000174 (Cellnovo System Starter Kit); All batches], manufactured by Cellnovo Ltd.
The manufacturer has recently become aware that in a very small number of cases, some users are deviating away from the Bolus Dose Calculator recommendation by as much as five or seven units.
When a user deviates away greatly from a bolus calculation recommendation, the user must be aware of the impact of doing so. If the next recommendation is taken within the users' pre-set 'time to target' and their blood glucose level has increased, then the next bolus recommendation will attempt to reduce the blood glucose level to mid-point within target range and also react to the deviation.
According to the manufacturer, the capability to deviate from the recommended value provided by the bolus dose calculator is common to most systems; however, affected users should be aware that either increasing or decreasing the recommendation by significant amounts (i.e. five or seven units) may lead to instances of hypoglycaemia or hyperglycaemia.
The affected users are advised to take the following actions:
The manufacturer is reviewing the alerts associated with this and where required will issue a handset software update very early in the new year, along with some scheduled enhancements.
For details, please refer to the following MHRA website:
https://www.gov.uk/drug-device-alerts/field-safety-notice-7-11-january-2019
If you are in possession of the products, please contact your supplier for necessary actions.
Posted on 15 January 2019