MEDICAL DEVICE ALERT: Blood glucose meters (21 December 2006)
The Medicines and Healthcare products Regulatory Agency has continued to receive reports of incidents in which the units of measurement displayed have changed from mmol/L to mg/dL on some blood glucose meters, including OneTouch Ultra, InDuo and PocketScan meters. These blood glucose meters are used with OneTouch Ultra or PocketScan test strips.
The units of measure may change if the meter is dropped, or if the battery
is changed when the meter is switched on. There may also be some meters
for which the units of measurement displayed can inadvertently be changed
by the user. LifeScan is planning a comprehensive meter replacement programme
for all affected meters and users can expect to be contacted by Lifescan
regarding this issue in early 2007.
Pharmacists supplying OneTouch Ultra or PocketScan test strips are asked
to advise the user to: check whether they have an affected meter and
if so to check the units of measurement displayed; be extra vigilant
at checking the units of measurement displayed every time they test,
especially if the meter is dropped or the battery has been changed; and
contact the LifeScan customer care line immediately (on 0800 028 8039)
for a replacement meter if their meter is reading in mg/dL. Meters can
continue to be used as long as users ensure that the meter is reading
in mmol/L every time they test. For instructions on how to do this users
should read the owner’s booklet or contact the customer care line.
This
alert is an addition to previous MHRA warnings (PJ, 14 May
2005, p579, 18 March, p317,
and 17 June, p715). |
