Accu-Chek® Compact test strips 에 대한 현장 안전성 서한

Field Safety Notice

SN2014(18)

2014-04-17

Ireland

HPRA

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

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.

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.