Events

Recall of D-TRONplus or Accu-Chek D-TRONplus series

According to L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), this recall involved a device in France that was produced by Roche Diagnostics.

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
  • Date
    2006-05-12
  • Event Country
    France
  • Event Source
    ANSM
  • Event Source URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/retrait-de-lots-de-piles-pour-pompes-a-insuline-d-tronplus-et-accu-chek-d-tronplus-roche-diagnostics
  • Notes / Alerts
    French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), 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 France.
  • Extra notes in the data
  • Action
    ROCHE Diagnostics has withdrawn batches 4017121, 4017242 and 6020002 of insulin pump batteries from the D-TRONplus or Accu-Chek D-TRONplus series from the market on May 10, 2006 following claims of sudden stops without alarm of these pumps .. The company has directly notified the recipients (distributors and associations) of the batches of incriminated batteries with the message attached (12/05/2006) (49 KB) validated by Afssaps. The distributors and associations concerned will inform patients who use these pumps that could have received batteries belonging to these batches (message in annex (12/05/2006) (33 KB)). The relevant European Competent Authorities are informed of this measurement by the manufacturer. Read auss. Alert of August 30, 2006

Device

D-TRONplus or Accu-Chek D-TRONplus series

Manufacturer

Roche Diagnostics