Events

Alerte Ou Avis De Sécurité sur All Accu-Chek® Insight insulin pumps

Selon Medicines and Healthcare products Regulatory Agency, ce/cet/cette alerte ou avis de sécurité concerne un dispositif en/au/aux/à United Kingdom qui a été fabriqué par Roche Diabetes Care.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert / Field Safety Notice
  • Numéro de l'événement
    MDA/2015/029
  • Date
    2015-08-04
  • Date de publication de l'événement
    2015-08-04
  • Pays de l'événement
    United Kingdom
  • Source de l'événement
    MHRA
  • URL de la source de l'événement
    https://www.gov.uk//drug-device-alerts/all-accu-chek-insight-insulin-pumps-risk-of-hyperglycaemia-from-rapid-pump-battery-depletion-or-unexpected-shut-down
  • Notes / Alertes
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 the United Kingdom.
  • Notes supplémentaires dans les données
    Roche has identified that the use of low-quality batteries or users incorrectly confirming the battery type in the pump settings can lead to unexpected rapid power depletion or a shutdown of the pump. If this goes undetected, patients could experience hyperglycaemia due to under delivery of insulin.Roche has provided updated handling instructions and battery model recommendations in their FSN issued in June 2015 (manufacturer’s reference: SB_RDC_2015_04) but has not had enough replies to know that healthcare providers and users have received and acted on this advice.
  • Cause
    (roche diabetes care) advice from manufacturer to users about the correct battery specification and appropriate pump settings (mda/2015/029).
  • Action
    Identify users of all Accu-Chek® Insight insulin pumps Ensure that all users receive the manufacturer’s field safety notice (FSN), understand the problem, use batteries meeting the specification detailed in the FSN and confirm battery type in the pump settings Ensure systems are in place to supply users of Accu-Chek® Insight insulin pumps with batteries meeting the specification advised by Roche Ensure that all users are aware that if they experience a rapid decrease in power they should contact the Accu-Chek® Pump Care Line on 0800 731 22 91 Complete and return the FSN acknowledgement form to Roche

Device

All Accu-Chek® Insight insulin pumps

Manufacturer

Roche Diabetes Care
  • Adresse du fabricant
    Roche Diabetes CareTel: 0800 731 2291burgesshill.insulinpumps@roche.comManufacturer FSCA Reference: SB_RDC_2017_04
  • Société-mère du fabricant (2017)
    Roche Holding Ag
  • Source
    MHRA