Events

Avis De Sécurité sur Accu-Chek® Compact test strips

Selon Health Products Regulatory Authority, ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Ireland qui a été fabriqué par Roche Diagnostics.

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
    Field Safety Notice
  • Numéro de l'événement
    SN2014(18)
  • Date
    2014-04-17
  • Pays de l'événement
    Ireland
  • Source de l'événement
    HPRA
  • URL de la source de l'événement
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/accu-chek-compact-test-strips.-priority-2---warning&id=b5cff925-9782-6eee-9b55-ff00008c97d0
  • Notes / Alertes
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 Ireland."
  • Notes supplémentaires dans les données
  • Cause
    Roche diabetes care has become aware of a limitation of accu-chek® compact test strips and accu-chek® mobile tests, which may lead to erroneously lowered blood glucose readings in patients undergoing ceftriaxone therapy (e.G. rocephin® or cefotrix®). this limitation is not described in the product labelling.
  • Action
    The IMB advises that users:  (1) Determine whether you receive therapies containing the antibiotic substance ceftriaxone.  (2) Do not use Accu-Chek® Compact test strips or Accu-Chek® Mobile tests throughout the duration of treatment with ceftriaxone.  (3) Ensure that you can continue to monitor your blood glucose appropriately. This should be done in consultation with your healthcare professional.  The IMB advises that healthcare professionals:  (1) Identify all patients who receive therapies containing the antibiotic substance ceftriaxone.  (2) Advise these patients not to use Accu-Chek® Compact test strips or Accu-Chek® Mobile tests throughout the duration of treatment with ceftriaxone.  (3) Ensure that these patients can continue to monitor their blood glucose appropriately by providing an alternative blood glucose monitoring system.  (4) Ensure that the appropriate personnel are made aware of this notice and the attached FSN. Please pass this Safety Notice and the attached FSN on to any end users or organisations where Accu-Chek® Compact Plus and Accu-Chek® Mobile systems may have been distributed.

Device

Accu-Chek® Compact test strips
  • Modèle / numéro de série
  • Description du dispositif
    Accu-Chek® Compact test strips. Priority 2 - Warning
  • Manufacturer
    Roche Diagnostics

Manufacturer

Roche Diagnostics