Events

Safety Alert for Dana Diabecare R Insulin Pump

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by SOOIL Development.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2013-02-14
  • Event Date Posted
    2013-02-14
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130214.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: sooil dana diabecare r insulin pump the medicines and healthcare products regulatory agency (mhra), united kingdom posted a medical device safety alert concerning dana diabecare r insulin pump, manufactured by sooil development. an update of instructions for use and software controlling minimal basal rate is required in existing/ in-use dana diabecare r insulin pumps having serial numbers beginning ajj, ak, al, and am manufactured after 20 sep 2009. the manufacturer advises that this pump model is unsuitable for delivery of minimal basal rates below 0.04u/h. the manufacturer advises affected users to take the following actions:- users should return the affected devices to the distributors for modification. in the immediate term, users who absolutely require a minimal basal rate of less than 0.04u/h, and whose pumps are so set, should seek an alternative model capable of the rate required and discontinue use of the dana diabecare r model in use as soon as possible, at the same time notifying the manufacturer or the distributor. users with pumps set through “doctor mode” to deliver 0.01u/h should reset them through the same means to deliver a minimal basal rate of not less than 0.04u/h, and notify the manufacturer or the distributor. distributors will contact every pump user to deliver revised ifu and with a view to upgrading the pump software to prevent setting of basal rates below 0.04u/h. pumps whose current software prevents use at minimal basal rate settings below 0.1 u/h (the default value) may be upgraded to provide a minimal basal rate of 0.04u/h only of the user so requires. according to the manufacturer, the affected devices were not distributed in hong kong. for details, please refer to mhra website http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/ fieldsafetynotices/con231539 if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 14 february 2013.

Device

Dana Diabecare R Insulin Pump
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: SOOIL Dana Diabecare R Insulin Pump
  • Manufacturer
    SOOIL Development

Manufacturer

SOOIL Development