Accu-Chek Spirit Combo insulin pump (Pumps with serial numbers in the range 10171897 to 10281629 inclusive) 에 대한 현장 안전성 서한

Field Safety Notice

SN2014(13)

2014-03-24

Ireland

HPRA

http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/accu-chek-spirit-combo-insulin-pump-(pumps-with-serial-numbers-in-the-range-10171897-to-10281629-inclusive)&id=52cdf925-9782-6eee-9b55-ff00008c97d0

There is an increased risk that, due to a component change, vibration alarm defects may cause an ‘e-7’ alert message. this fault will be detected at pump start up, when it will display an ‘e-7’ error message and give an audible signal, but will fail to start. the other pump alarms – visual and audible - are not affected by this issue. pumps with serial numbers in the range 10171897 to 10281629 (inclusive) are potentially affected. these pumps were distributed to the irish market between late 2010 and early 2012 and to date, no ‘e-7’ issues related to vibration alarm defects have been reported from ireland.

1. Identify affected pumps.  2. If a delay to insulin therapy could compromise patient safety, consider using an alternative device.  3. When using these pumps:  • Ensure that users are aware of the problem  • Ensure that users have a syringe or insulin pen available in case the pump stops  • If the pump displays an ‘E-7’ error, contact Roche for a replacement device  4. Ensure that appropriate personnel are made aware of this notice. Please also pass this notice on to any end user or organisation where the potentially affected insulin pumps have been transferred