Events

Alerte De Sécurité sur Lifescan OneTouch Verio Pro, OneTouch Verio IQ, and OneTouch Verio Pro+ blood glucose meters

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Lifescan.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Date
    2013-03-26
  • Date de publication de l'événement
    2013-03-26
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130326a.html
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    Medical device safety alert: lifescan onetouch verio pro, onetouch verio iq, and onetouch verio pro+ blood glucose meters the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning onetouch verio pro, onetouch verio iq, and onetouch verio pro+ blood glucose meters, manufactured by lifescan. regarding onetouch verio pro and onetouch verio pro+, at blood glucose levels of 33.3 mmol/l] and above, the meter should display a warning that says “extreme high bg above [33.3 mmol/l].” however, at extremely high blood glucose levels of [56.8 mmol/l] and above, the meters will display and store in memory an incorrect test result that is [56.8 mmol/l] below the measured result. regarding onetouch verio iq, at extremely high blood glucose levels of 56.8 mmol/l and above, the meter will turn off instead of displaying the message “extreme high glucose above 33.3 mmol/l” as intended. when turned back on, the meter enters the set-up mode and requires the user to confirm the date and time settings before being able to test again. however, if the glucose level is still 56.8 mmol/l or above when testing, the meter will shut down again. both of the above situations can cause delay in the diagnosis of severe hyperglycemia. the manufacturer advises patients to discontinue use of this meter immediately and use another meter for testing their blood glucose. furthermore, lifescan will be conducting a global recall to remove all of the affected meters from the market. according to the local supplier, the affected products were not distributed in hong kong. for details, please refer to mhra website http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/ fieldsafetynotices/con249653 if you are in possession of the product, please contact your supplier for necessary actions. posted on 26 march 2013.

Device

Lifescan OneTouch Verio Pro, OneTouch Verio IQ, and OneTouch Verio Pro+ blood glucose meters

Manufacturer

Lifescan