Events

Alerte De Sécurité sur LifeScan OneTouch Ultra 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 Johnson & Johnson.

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
    2006-12-19
  • 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/press_20061219.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
    Press release
  • Cause
    Dh closely monitoring safety of lifescan blood glucose meter the department of health (dh) was notified by johnson & johnson (hong kong) limited that the company was following up whether the lifescan onetouch ultra blood glucose meters supplied to hong kong were of the same design and software as those available in united kingdom. a dh spokesman said that the unit of measurement of some meters of this model in united kingdom might change from mmol/l to mg/dl if the meter was dropped or if the battery was changed when the meter was switched on. the spokesman said, "as a precautionary measure, users of any brands of blood glucose meters should always check and ensure that the unit of measurement is in mmol/l in every test. if the unit of measurement is in mg/dl, they should immediately contact their suppliers." "members of the public are advised to follow strictly instructions in the manual when using blood glucose meters." the spokesman said that dh had informed the public and private hospitals, nursing homes, medical professional associations, and diabetes patient support groups about this safety issue. dh has not received any report of adverse events related to the unit of measurement issue, he added. relevant information has also been posted on the mdco website http://www.Mdco.Gov.Hk/english/recalls/recalls.Html . ends/tuesday, december 19, 2006 nnnn.

Device

LifeScan OneTouch Ultra blood glucose meters
  • Modèle / numéro de série
  • Description du dispositif
    Press release: DH Closely Monitoring Safety of Lifescan Blood Glucose Meter
  • Manufacturer
    Johnson & Johnson

Manufacturer

Johnson & Johnson