Events

Safety Alert for ACCU – CHEK SPIRIT

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Disetronic Medical System AG.

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
  • Event ID
    I1406-238
  • Event Number
    2008DM-0002610
  • Date
    2014-06-09
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=202
  • Notes / Alerts
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 recall data from the U.S. and Colombia.
  • Extra notes in the data
  • Reason
    The manufacturer reports that a defective component in the aforementioned devices can generate an error message "e7: electronic error" and an acoustic signal, this situation prevents the device from working, which can lead to possible adverse events on the patient.

Device

ACCU – CHEK SPIRIT
  • Model / Serial
    Series: 10171897 to 10281629
  • Product Description
    Portable equipment whose only function is the subcutaneous and continuous administration of short-acting insulin or rapid-acting insulin-analogue in 100, 50, 40 or 10 international units. Recommended in patients with insulin-dependent diabetes mellitus.
  • Manufacturer
    Disetronic Medical System AG

Manufacturer

Disetronic Medical System AG