RECALLS

Home > Recalls / Product alerts / Drug alerts

PRODUCT ALERT: Blood glucose meters (10 June 2006)

The Medicines and Healthcare products Regulatory Agency has continued to receive reports of adverse incidents where the units of measurement displayed on a number of blood glucose meters have changed from mmol/L to mg/dL, leading the user to think that that the blood glucose level is 18 times higher than it is. The affected meters are FreeStyle and FreeStyle Mini (previously known as TheraSense) and MediSense Optium Xceed manufactured by Abbott Diabetes Care The units of measurement can be inadvertently changed and, on FreeStyle and FreeStyle Mini meters, may also change spontaneously following continued use of the meters once the low battery sign has appeared.

The manufacturer will replace, free of charge, affected meters with new ones for which the unit of measurement cannot be changed. In the meantime, the user should ensure that the meter reads in mmol/L every time they test. Batteries should be changed immediately when the low battery symbol appears.

Affected meters include those with the following serial numbers on the back of the meter:

Pharmacists are asked not to supply affected meters and to contact Abbott pharmacy line (0800 3168884) for a free replacement. When dispensing Freestyle test strips and Optium Plus test strips, pharmacists should advise the user to contact Abbott (0500 467466) to find out whether they need a replacement meter.

Customers can continue to use their meters before contacting Abbott as long as they ensure that meters are reading in mmol/L. This alert updates one issued earlier this year (PJ, 18 March, p317).

In a statement, the MHRA also reminds health care professionals and patients that LifeScan OneTouch, LifeScan InDuo and LifeScan PocketScan, manufactured by LifeScan, are also affected by this problem (PJ, 14 May 2005, p579).