Events

Recall of CONTOUR NEXT control solutions. In vitro diagnostic medical device (IVD). MiniMed Paradigm insulin infusion pumps, MiniMed NGP Pumps, MiniMed Guardian Monitor REAL-Time and CONTOUR NEXT test strips.

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Bayer Australia Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2015-RN-00746-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2015-08-27
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00746-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    Contour next control solutions. in vitro diagnostic medical device (ivd)contournext control solutions are used with contour next test strips andcontournext family meters (contour xt/next ez, contour next, contour next link, contour next link 2.4, contour next usb), medtronic minimed paradigm insulin infusion pumps, minimed ngp pumps medtronic minimed guardian monitor real-time . all lots of control solution are affectedartg number: 191635.
  • Action
    Bayer is notifying healthcare professionals of changes to the instructions for use. The additional instructions provide detailed information on the proper handling of Contour Next controls. Bayer is also notifying health care professionals that if a CONTOUR NEXT control test result is outside of the control range, make sure to follow the instructions above, and perform another control test.

Device

CONTOUR NEXT control solutions. In vitro diagnostic medical device (IVD). MiniMed Paradigm insuli...
  • Model / Serial
    CONTOUR NEXT control solutions. In vitro diagnostic medical device (IVD).MiniMed Paradigm insulin infusion pumps (MMT- 512, MMT-712, MMT-515, MMT-715, MMT-522, MMT-522K, MMT-722, MMT-722K, MMT- 523, MMT523K, MMT-723, MMT-723K, MMT-551, MMT-751, MMT-554 and MMT-754), MiniMed NGP Pumps (MMT-1510, MMT-1511, MMT-1512, MMT-1580, & MMT- 1712), MiniMed Guardian Monitor REAL-Time (CSS7100 & CSS7200) and CONTOUR NEXT test strips. All lots of control solution are affected.
  • Manufacturer
    Bayer Australia Ltd

Manufacturer

Bayer Australia Ltd
  • Manufacturer Parent Company (2017)
    Bayer AG
  • Source
    DHTGA