Events

Alerte De Sécurité sur ADVIA Chemistry Systems A1c_3 calibrator

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Siemens Healthcare 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
    2014-08-22
  • Date de publication de l'événement
    2014-08-22
  • 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_20140822.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: siemens advia chemistry systems a1c_3 calibrator medical device manufacturer, siemens healthcare diagnostics, has issued a medical device safety alert concerning its advia chemistry systems a1c_3 calibrator [catalogue no.: 10491408 & lot no.: 3hd044; 3ld068]. the manufacturer is conducting a recall of the advia chemistry systems a1c_3 calibrator lots 3hd044 and 3ld068. the manufacturer has confirmed that the advia chemistry systems a1c_3 method may exhibit a percent bias of -9% to +11% for hemoglobin (hb)a1c samples when using a1c_3 calibrator lots 3hd044 and 3ld068. depending on quality control limits, this issue may not have been detected. note: the percent bias range is a percentage of the hba1c result. it is not absolute hba1c units. according to the manufacturer, a percent bias of up to +11% may be considered clinically significant at clinically relevant hba1c ranges between ~5.5% and 8.0%, and may result in the modification of the therapy for hyperglycemia. the modification of hyperglycemic therapy can increase the risk of occurrence of hypoglycemia, which may be observed through personal glucose monitoring and/or patient symptoms. affected users are advised to discontinue use of and discard the affected products. the manufacturer is not recommending a general look back for the laboratory for previously generated results when using these calibrator lots. the manufacturer is also providing a physician letter with retesting guidance for physicians. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 22 aug 2014.

Device

ADVIA Chemistry Systems A1c_3 calibrator
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Siemens ADVIA Chemistry Systems A1c_3 calibrator
  • Manufacturer
    Siemens Healthcare Diagnostics

Manufacturer

Siemens Healthcare Diagnostics