Alerte De Sécurité sur ACCU-CHEK Performa Strip

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

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
    2011-06-21
  • Pays de l'événement
  • Source de l'événement
    DH
  • URL de la source de l'événement
  • 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
    Safety alert over roche blood glucose strip the department of health (dh) today (june 21) draws public's attention to the recall of a medical device in france, accu-chek performa strip, a blood glucose test strip of roche diagnostics, as the strip may give falsely high blood sugar reading, thereby has the potential to cause fatal mis-management of diabetic patients. the alert comes to dh's notice through its surveillance system on medical device mishaps.  accu-chek performa strip is meant for used together with its home-use performa system by diabetic patients for self- monitoring of their blood glucose status. according to information available to the us food and drug administration, a specific lot (batch no.:470049) of the test strip referred to has the above deficiency. a spokesman for dh explains that falsely high blood glucose reading may cause a diabetic patient to mis-handle his condition, resulting in the life-threatening condition of hypoglycaemia. preliminary enquiry on the local supplier, roche diagnostics (hong kong) limited revealed that the affected lot of performa blood glucose strip is for sale in france only and has not been imported into hong kong. “though the affected lot has not been introduced into the hong kong market, the possibility of possession by individual diabetic patients cannot be ruled out, mindful of the option of internet trading and also the abundance of international travellers in hong kong. because of the dreaded consequences here, dh opts that a public alert is still warranted,”the spokesman stresses. "any one who has the failed lot of device in his possession must stop using it and contact roche diagnostic (hong kong) for follow-up," the spokesman urges. it is understood that the company has set up a hotline 2485 7512 to handle the matter. so far, the dh has not received any report of adverse events arising from use of the affected product.  however, the spokesman does remind that for those customers who have used the said product and are either feeling unwell or in doubt, they should consult their healthcare professionals for advice as soon as possible.

Device

  • Modèle / numéro de série
  • Description du dispositif
    Press release: Safety alert over Roche blood glucose strip
  • Manufacturer

Manufacturer