MDA/2014/008: Insulin Infusion Pump Manufactured by Roche Diagnostics Ltd

This Medical Device Alert is being issued as there is a risk of delay of treatment when using insulin infusion pumps manufactured by Roche Diagnostics Ltd.


Insulin infusion pump:
Accu-Chek Spirit Combo insulin pump
Manufactured by Roche Diagnostics Ltd.

All pumps with serial numbers in the range 10171897 to 10281629 (inclusive).

Risk of delay to treatment.

There is an increased risk that the vibration alarm will not work, as a result of a changed component. This fault will only 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.

Roche will replace pumps that display this 'E-7' error message, but does not intend to replace all potentially affected pumps.

Full alert download.



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