Events

Safety Alert for Accu-Chek Insight insulin pump cartridge (self-filled)

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

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
    2015-03-03
  • Event Date Posted
    2015-03-03
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150303.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: accu-chek insight insulin pump cartridge (self-filled) the medicines and healthcare products regulatory agency (mhra) posted a medical device safety alert concerning accu-chek insight insulin pump cartridge (self-filled) manufactured by roche diagnostics. [lot numbers: 1083036, 1083193, 1083533, 1083534, 1083535, 1083536, 1083537, 1089205, 1089206, 1090593, 1090763, 1091203, 1091204, d04032014, d14112013] the manufacturer has become aware of a potential insulin leakage occurring with some manufacturing lots of the accu-chek insight insulin pump cartridge (self-filled) used with the accu-chek insight insulin pump system. the potential risk is smaller than expected doses of insulin may be delivered if insulin leakage occurs. patient may experience too high blood glucose levels, which if left untreated, can result in a diabetic ketoacidosis. death could result. the manufacturer is advising end users not to use and discard any cartridges of the above listed lots. according to the local supplier, the affected products are not distributed in hong kong. for details, please refer to the following link: http://mhra.Filecamp.Com/public/file/28bg-c089h6uh if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 03 march 2015.

Device

Accu-Chek Insight insulin pump cartridge (self-filled)
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Accu-Chek Insight insulin pump cartridge (self-filled)
  • Manufacturer
    Roche Diagnostics

Manufacturer

Roche Diagnostics