Events

Field Safety Notices about Accu-Chek® Compact test strips

According to Health Products Regulatory Authority, this field safety notices involved a device in Ireland that was produced by Roche Diagnostics.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Event Number
    SN2014(18)
  • Date
    2014-04-17
  • Event Country
    Ireland
  • Event Source
    HPRA
  • Event Source URL
    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 / Alerts
    "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."
  • Extra notes in the data
  • Reason
    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
  • Model / Serial
  • Product Description
    Accu-Chek® Compact test strips. Priority 2 - Warning
  • Manufacturer
    Roche Diagnostics

Manufacturer

Roche Diagnostics